Import Alert 54-14
(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 54-14
Published Date: 01/22/2026
Type: DWPE
Import Alert Name:
DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 10/26/2023 updates the IA name, reason for alert, guidance section including agency contacts, charge code language, and product description section. Changes to the import alert are bracketed by asterisks (***).
Section 402(g)(2) of the Federal Food, Drug, and Cosmetic Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices (GMP) for dietary supplements. On June 25, 2007, FDA published a final rule setting out the GMP requirements for dietary supplements in the Federal Register ***[72 FR 34752].***
The final rule created Title 21, part 111 (21 CFR Part 111), which established the minimum current GMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Per the regulation, quality means that the dietary supplement consistently meets the established specifications for the identity, purity, strength, and composition, ***and for limits on those types of contaminations that may adulterate or that may lead to adulteration of the finished batch of the product.*** Any dietary supplement imported or offered for import into the United States is subject to the aforementioned regulation.
FDA performs foreign inspections of dietary supplement manufacturers to determine compliance with the regulation. FDA may ***detain without physical examination (DWPE) and refuse admission of affected dietary supplements if inspection has revealed that a firm is not operating in conformity with current GMPs.***
When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement ***product(s) may*** be removed from detention without physical examination.
Section 402(g)(2) of the Federal Food, Drug, and Cosmetic Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices (GMP) for dietary supplements. On June 25, 2007, FDA published a final rule setting out the GMP requirements for dietary supplements in the Federal Register ***[72 FR 34752].***
The final rule created Title 21, part 111 (21 CFR Part 111), which established the minimum current GMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Per the regulation, quality means that the dietary supplement consistently meets the established specifications for the identity, purity, strength, and composition, ***and for limits on those types of contaminations that may adulterate or that may lead to adulteration of the finished batch of the product.*** Any dietary supplement imported or offered for import into the United States is subject to the aforementioned regulation.
FDA performs foreign inspections of dietary supplement manufacturers to determine compliance with the regulation. FDA may ***detain without physical examination (DWPE) and refuse admission of affected dietary supplements if inspection has revealed that a firm is not operating in conformity with current GMPs.***
When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement ***product(s) may*** be removed from detention without physical examination.
Guidance:
***Divisions may detain without physical examination the listed dietary supplement products from the foreign processors (manufacturers) identified on the Red List of this import alert.***
DWPE is indicated when CFSAN determines that inspectional findings demonstrate that dietary supplement products have not been manufactured in conformity with current GMPs. ***Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).***
***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide documentation that the GMP violation(s) for the affected product(s) have been adequately corrected. CFSAN will review a firm's documentation to determine whether an individual shipment of an entry may be released.***
***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List of this import alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. Such information should provide the Agency confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant documentation supporting the corrective actions for the GMP violations should be sent via email to:
Importalerts2@fda.hhs.gov
***
Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
DWPE is indicated when CFSAN determines that inspectional findings demonstrate that dietary supplement products have not been manufactured in conformity with current GMPs. ***Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).***
***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:
In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide documentation that the GMP violation(s) for the affected product(s) have been adequately corrected. CFSAN will review a firm's documentation to determine whether an individual shipment of an entry may be released.***
***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List of this import alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. Such information should provide the Agency confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant documentation supporting the corrective actions for the GMP violations should be sent via email to:
Importalerts2@fda.hhs.gov
***
Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov.
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov
***
Product Description:
Dietary Supplements, Bulk or Finished
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to have been prepared, packed, or held under conditions that do not meet current good manufacturing practices. [Adulteration, 402(g)(1)]
OASIS charge code: SUPPL GMP***
OASIS charge code: SUPPL GMP***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
AUSTRALIA
BJP Laboratories Pty Ltd
Date Published : 07/16/2020
35 Computer Rd
, Yatala,
Queensland AUSTRALIA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
04 - - - -- Macaroni/Noodle Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
07 - - - -- Snack Food Items
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
12 - - - -- Cheese/Cheese Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
13 - - - -- Ice Cream and related Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
15 - - - -- Eggs/Egg Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
16 - - - -- Fishery/Seafood Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
17 - - - -- Meats, Meat Products and Poultry
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
18 - - - -- Vegetable Protein Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
20 - - - -- Fruit/Fruit Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
21 - - - -- Fruit/Fruit Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
22 - - - -- Fruit/Fruit Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
23 - - - -- Nuts/Edible Seeds
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
24 - - - -- Vegetables/Vegetable Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
25 - - - -- Vegetables/Vegetable Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
26 - - - -- Vegetable Oils
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
27 - - - -- Dressing/Condiments
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
28 - - - -- Spices, Flavors And Salts
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
31 - - - -- Coffee/Tea
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
32 - - - -- Alcoholic Beverages
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
38 - - - -- Soups
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
39 - - - -- Prepared Salad Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 A - - -- Baked Goods (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 B - - -- Cereal (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 D - - -- Veg (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 J - - -- Egg Prod (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 K - - -- Pudding/Custard (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 X - - -- Market Basket Sampling
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 Y - - -- Baby Food N.E.C.
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 B - - -- Milled Edible Insect Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 C - - -- Edible Insect Bars
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 D - - -- Edible Insect Bakery Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 G - - -- Edible Insect Capsules
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 I - - -- Edible Insect Jerky
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 K - - -- Edible Insect Oils
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 L - - -- Edible Insect Smoothies
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 M - - -- Edible Insect Soups
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 O - - -- Edible Insect Beverages
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 Q - - -- Edible Insect Salts and Spices
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 R - - -- Edible Insect Products N.E.C.
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 06 Corn Husks (Food Related)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 07 Snail Shells (Food Related)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 12 Non-Edible Bird's Nest
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 D - - -- Live Animals
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/16/2020
Desc: All Dietary Supplement Products
Bjp Laboratories Pty Ltd
Date Published : 07/16/2020
2/38 Computer street
, Yatala,
Queensland AUSTRALIA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
04 - - - -- Macaroni/Noodle Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
07 - - - -- Snack Food Items
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
12 - - - -- Cheese/Cheese Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
13 - - - -- Ice Cream and related Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
15 - - - -- Eggs/Egg Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
16 - - - -- Fishery/Seafood Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
17 - - - -- Meats, Meat Products and Poultry
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
18 - - - -- Vegetable Protein Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
20 - - - -- Fruit/Fruit Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
21 - - - -- Fruit/Fruit Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
22 - - - -- Fruit/Fruit Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
23 - - - -- Nuts/Edible Seeds
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
24 - - - -- Vegetables/Vegetable Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
25 - - - -- Vegetables/Vegetable Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
26 - - - -- Vegetable Oils
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
27 - - - -- Dressing/Condiments
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
28 - - - -- Spices, Flavors And Salts
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
31 - - - -- Coffee/Tea
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
32 - - - -- Alcoholic Beverages
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
38 - - - -- Soups
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
39 - - - -- Prepared Salad Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 A - - -- Baked Goods (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 B - - -- Cereal (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 D - - -- Veg (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 J - - -- Egg Prod (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 K - - -- Pudding/Custard (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 X - - -- Market Basket Sampling
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
40 Y - - -- Baby Food N.E.C.
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 B - - -- Milled Edible Insect Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 C - - -- Edible Insect Bars
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 D - - -- Edible Insect Bakery Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 G - - -- Edible Insect Capsules
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 I - - -- Edible Insect Jerky
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 K - - -- Edible Insect Oils
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 L - - -- Edible Insect Smoothies
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 M - - -- Edible Insect Soups
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 O - - -- Edible Insect Beverages
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 Q - - -- Edible Insect Salts and Spices
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
42 R - - -- Edible Insect Products N.E.C.
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 06 Corn Husks (Food Related)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 07 Snail Shells (Food Related)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 B - - 12 Non-Edible Bird's Nest
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
52 D - - -- Live Animals
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/16/2020
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/16/2020
Desc: All Dietary Supplement Products
Steric Trading Pty Ltd
Date Published : 07/11/2025
33-61 Malta Street
, Fairfield East,
New South Wales AUSTRALIA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2025
Desc: Collagen Inner Beauty Boost
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2025
Desc: Clear Skin Inner Beauty Support
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2025
Desc: Glow Ageless Inner Beauty Essential
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2025
Desc: Hydration Inner Beauty Boost
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/11/2025
Desc: Antioxidant Inner Beauty Boost
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
BELGIUM
LAMBO Laboratoria
Date Published : 01/09/2023
Industriepark Den Hoek 3 , Simon De Heuvellaan 4
, Wijnegem,
Antwerp BELGIUM
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 01/09/2023
Desc: All Dietary Supplement Products
Notes: Some examples (not an all-inclusive list) of dietary supplement products manufactured by the firm include: Terry Naturally brand Artery Strong, Terry Naturally brand Bacteril, Terry Naturally brand BosMed Intestinal Bowel Support, Terry Naturally brand BosMed Respiratory Support, Terry Naturally brand Fresh Breath Gels, Terry Naturally brand Hair Renew Formula, Terry Naturally brand Omega 7, Terry Naturally brand SinuCare with Eucalyptus, Terry Naturally brand Terrific Zzzz, Terry Naturally brand SinuCare Extra Strength.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/09/2023
Desc: All Dietary Supplement Products
Notes: Some examples (not an all-inclusive list) of dietary supplement products manufactured by the firm include: Terry Naturally brand Artery Strong, Terry Naturally brand Bacteril, Terry Naturally brand BosMed Intestinal Bowel Support, Terry Naturally brand BosMed Respiratory Support, Terry Naturally brand Fresh Breath Gels, Terry Naturally brand Hair Renew Formula, Terry Naturally brand Omega 7, Terry Naturally brand SinuCare with Eucalyptus, Terry Naturally brand Terrific Zzzz, Terry Naturally brand SinuCare Extra Strength.
BRAZIL
Riclan S.A.
Date Published : 06/04/2025
Avenida Presidente Kennedy, 754
, Rio Claro,
Sao Paulo BRAZIL
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/04/2025
Desc: Vitamin C drops
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for the Dietary Supplement Vitamin C drops , Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.70 (b), 21 CFR 111.70 (b)(2), 21 CFR 111.75 (a)(1)(i), 21 CFR 111.70 (e), 21 CFR 111.210 (h)(1), 21 CFR 210 (h)(5), 21 CFR 260, and 21 CFR 111.210 (h)(2), indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
33 L - - 06 Flavored Candy, Soft (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/04/2025
Desc: Vitamin C drops
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for the Dietary Supplement Vitamin C drops , Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.70 (b), 21 CFR 111.70 (b)(2), 21 CFR 111.75 (a)(1)(i), 21 CFR 111.70 (e), 21 CFR 111.210 (h)(1), 21 CFR 210 (h)(5), 21 CFR 260, and 21 CFR 111.210 (h)(2), indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 06/04/2025
Desc: Vitamin C drops
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for the Dietary Supplement Vitamin C drops , Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.70 (b), 21 CFR 111.70 (b)(2), 21 CFR 111.75 (a)(1)(i), 21 CFR 111.70 (e), 21 CFR 111.210 (h)(1), 21 CFR 210 (h)(5), 21 CFR 260, and 21 CFR 111.210 (h)(2), indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
Riclan S.A.
Date Published : 06/02/2025
Avenida Brasil 4801
, Rio Claro,
Sao Paulo BRAZIL
33 E - - 06 Flavored Candy, Hard (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/02/2025
Desc: Vitamin C drops
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for the Dietary Supplement Vitamin C drops , Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.70 (b), 21 CFR 111.70 (b)(2), 21 CFR 111.75 (a)(1)(i), 21 CFR 111.70 (e), 21 CFR 111.210 (h)(1), 21 CFR 210 (h)(5), 21 CFR 260, and 21 CFR 111.210 (h)(2), indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
33 L - - 06 Flavored Candy, Soft (Live Savers, Etc.), without Nuts and Fruit (without Chocolate)
Date Published: 06/02/2025
Desc: Vitamin C drops
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for the Dietary Supplement Vitamin C drops , Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.70 (b), 21 CFR 111.70 (b)(2), 21 CFR 111.75 (a)(1)(i), 21 CFR 111.70 (e), 21 CFR 111.210 (h)(1), 21 CFR 210 (h)(5), 21 CFR 260, and 21 CFR 111.210 (h)(2), indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 A - - 13 Vitamin C (Ascorbic Acid)
Date Published: 06/02/2025
Desc: Vitamin C drops
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for the Dietary Supplement Vitamin C drops , Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.70 (b), 21 CFR 111.70 (b)(2), 21 CFR 111.75 (a)(1)(i), 21 CFR 111.70 (e), 21 CFR 111.210 (h)(1), 21 CFR 210 (h)(5), 21 CFR 260, and 21 CFR 111.210 (h)(2), indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
CANADA
Celex Laboratories Inc.
Date Published : 08/19/2022
115-21600 Westminster Hwy
, Richmond,
British Columbia CANADA
54 B - - 07 Iron (Mineral)
Date Published: 08/19/2022
Desc: VORST IRON
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2022
Desc: VORST Advanced Join Formula
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2022
Desc: VORST IRON
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2022
Desc: Vorst Alpha Lipoic Acid
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/19/2022
Desc: VORST IRON
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/19/2022
Desc: Vorst Alpha Lipoic Acid
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/19/2022
Desc: VORST Advanced Join Formula
Notes: The FDA inspected the above referenced foreign food manufacturing facility from February 22 to 25, 2022 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears the (products) are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
HERBALAND NATURALS INC
Date Published : 08/30/2024
12280 Horseshoe Way
, Richmond,
British Columbia CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/27/2025
Desc: All dietary supplement products
HERBALAND NATURALS INC
Date Published : 07/03/2024
13330 Maycrest Way
, Richmond,
British Columbia CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/27/2025
Desc: All dietary supplement products
Herbaland Naturals Inc
Date Published : 07/02/2024
12340 Horseshoe Way
, Richmond,
British Columbia CANADA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/27/2025
Desc: All dietary supplement products
NNS Organics Limited
Date Published : 04/27/2023
2769 Lawrencetown Rd
, Lawrencetown,
Nova Scotia CANADA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 04/27/2023
Desc: Women's Mena and Meno Balance Formula
Notes: Based on FDA’s inspection of the above referenced foreign food manufacturing facility from June 6 through June 9, 2022, FDA found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements in violation of 21 CFR 111. It appears the Women’s Mena and Meno Balance Formula dietary supplement product is adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
NuEra Nutraceutical Inc
Date Published : 06/21/2022
12031 No. 5 Rd
, Richmond,
British Columbia CANADA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
04 - - - -- Macaroni/Noodle Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
07 - - - -- Snack Food Items
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
12 - - - -- Cheese/Cheese Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
13 - - - -- Ice Cream and related Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
15 - - - -- Eggs/Egg Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
16 - - - -- Fishery/Seafood Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
17 - - - -- Meats, Meat Products and Poultry
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
18 - - - -- Vegetable Protein Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
20 - - - -- Fruit/Fruit Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
21 - - - -- Fruit/Fruit Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
22 - - - -- Fruit/Fruit Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
23 - - - -- Nuts/Edible Seeds
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
24 - - - -- Vegetables/Vegetable Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
25 - - - -- Vegetables/Vegetable Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
26 - - - -- Vegetable Oils
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
27 - - - -- Dressing/Condiments
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
28 - - - -- Spices, Flavors And Salts
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
31 - - - -- Coffee/Tea
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
32 - - - -- Alcoholic Beverages
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
38 - - - -- Soups
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
39 - - - -- Prepared Salad Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 A - - -- Baked Goods (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 B - - -- Cereal (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 D - - -- Veg (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 J - - -- Egg Prod (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 K - - -- Pudding/Custard (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 X - - -- Market Basket Sampling
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
40 Y - - -- Baby Food N.E.C.
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 B - - -- Milled Edible Insect Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 C - - -- Edible Insect Bars
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 D - - -- Edible Insect Bakery Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 G - - -- Edible Insect Capsules
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 I - - -- Edible Insect Jerky
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 K - - -- Edible Insect Oils
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 L - - -- Edible Insect Smoothies
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 M - - -- Edible Insect Soups
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 O - - -- Edible Insect Beverages
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 Q - - -- Edible Insect Salts and Spices
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
42 R - - -- Edible Insect Products N.E.C.
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
52 B - - 06 Corn Husks (Food Related)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
52 B - - 07 Snail Shells (Food Related)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
52 B - - 12 Non-Edible Bird's Nest
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
52 D - - -- Live Animals
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/21/2022
Notes: All Dietary Supplement Products; GMP deviations noted during FDA foreign inspection of firm.
Nutralab Canada Corp.
Date Published : 09/27/2024
980 Tapscott Rd
, Scarborough,
Ontario CANADA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Detox Powder (Natural Pineapple Flavor)
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Plant-Based Formula Energy & Stamina Powder (Natural Pineapple Flavor)
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Daily Greens Boost Powder (Pineapple-Coconut Flavor)
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Noor Vitamins Vitamin D3 Softgels
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Immune & Antioxidants Powder (Natural French Vanilla Flavor)
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Daily Greens Boost Powder (Raspberry-Lemon Flavor)
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Vitality & Brain Powder (Natural Pineapple-Coconut Flavor)
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Noor Vitamins Prenatal DHA Ginger Softgels
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Noor Vitamins Hair & Skin Softgels
Notes:
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/27/2024
Desc: Active Green Pro Fiber Boost Prebiotic Probiotic Powder (Unflavored)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Pro Fiber Boost Prebiotic Probiotic Powder (Unflavored)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Vitality & Brain Powder (Natural Pineapple-Coconut Flavor)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Daily Greens Boost Powder (Raspberry-Lemon Flavor)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Detox Powder (Natural Pineapple Flavor)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Daily Greens Boost Powder (Pineapple-Coconut Flavor)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Noor Vitamins Vitamin D3 Softgels
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Pro Plant-Based Formula Immune & Antioxidants Powder (Natural French Vanilla Flavor)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Noor Vitamins Prenatal DHA Ginger Softgels
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Active Green Plant-Based Formula Energy & Stamina Powder (Natural Pineapple Flavor)
Notes:
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/27/2024
Desc: Noor Vitamins Hair & Skin Softgels
Notes:
Pharmalab 1982 Inc. Dba. Ideal Protein
Date Published : 01/18/2023
8750 Guillaume-Couture Blvd
, Levis,
Quebec CANADA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 01/18/2023
Desc: Multi-Vita K2 Multi-Vitamin and Mineral Supplement
Notes: Deficiencies in Dietary Supplement GMP requirements revealed during establishment inspection of firm conducted by FDA
54 A - - 90 Multiple Vitamins (MVI-12 vitamin combo) (Vitamin)
Date Published: 01/18/2023
Desc: Multi-Vita Multi-Vitamin and Mineral Supplement
Notes: Deficiencies in Dietary Supplement GMP requirements revealed during establishment inspection of firm conducted by FDA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/18/2023
Desc: Multi-Vita K2 Multi-Vitamin and Mineral Supplement
Notes: Deficiencies in Dietary Supplement GMP requirements revealed during establishment inspection of firm conducted by FDA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/18/2023
Desc: Multi-Vita Multi-Vitamin and Mineral Supplement
Notes: Deficiencies in Dietary Supplement GMP requirements revealed during establishment inspection of firm conducted by FDA
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 01/18/2023
Desc: Raspberry Hydrolyzed Collagen Liquid Dietary Supplement
Notes: Deficiencies in Dietary Supplement GMP requirements revealed during establishment inspection of firm conducted by FDA
Prime Health Products
Date Published : 07/31/2020
133 The West Mall Unit 8
, Etobicoke,
Ontario CANADA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
04 - - - -- Macaroni/Noodle Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
07 - - - -- Snack Food Items
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
12 - - - -- Cheese/Cheese Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
13 - - - -- Ice Cream and related Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
15 - - - -- Eggs/Egg Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
16 - - - -- Fishery/Seafood Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
17 - - - -- Meats, Meat Products and Poultry
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
18 - - - -- Vegetable Protein Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
20 - - - -- Fruit/Fruit Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
21 - - - -- Fruit/Fruit Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
22 - - - -- Fruit/Fruit Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
23 - - - -- Nuts/Edible Seeds
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
24 - - - -- Vegetables/Vegetable Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
25 - - - -- Vegetables/Vegetable Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
26 - - - -- Vegetable Oils
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
27 - - - -- Dressing/Condiments
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
28 - - - -- Spices, Flavors And Salts
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
31 - - - -- Coffee/Tea
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
32 - - - -- Alcoholic Beverages
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
38 - - - -- Soups
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
39 - - - -- Prepared Salad Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 A - - -- Baked Goods (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 B - - -- Cereal (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 D - - -- Veg (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 J - - -- Egg Prod (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 K - - -- Pudding/Custard (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 X - - -- Market Basket Sampling
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
40 Y - - -- Baby Food N.E.C.
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 B - - -- Milled Edible Insect Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 C - - -- Edible Insect Bars
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 D - - -- Edible Insect Bakery Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 G - - -- Edible Insect Capsules
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 I - - -- Edible Insect Jerky
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 K - - -- Edible Insect Oils
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 L - - -- Edible Insect Smoothies
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 M - - -- Edible Insect Soups
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 O - - -- Edible Insect Beverages
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 Q - - -- Edible Insect Salts and Spices
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
42 R - - -- Edible Insect Products N.E.C.
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
52 B - - 06 Corn Husks (Food Related)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
52 B - - 07 Snail Shells (Food Related)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
52 B - - 12 Non-Edible Bird's Nest
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
52 D - - -- Live Animals
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/31/2020
Notes: All Dietary Supplement Products
CHINA
Hubei Minkang Pharmaceutical Co., Ltd.
Date Published : 04/24/2017
NO. 50 Xiba Road
, Yichang,
Hubei CHINA
54 E - - -- Herbal and Botanical
Date Published: 04/24/2017
Desc: Huang Lian Su Herbal Supplement Tablets
54 E - - -- Herbal and Botanical
Date Published: 04/24/2017
Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017
Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets
54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017
Desc: Huang Lian Su Herbal Supplement Tablets
54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017
Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets
54 J - - -- Herbal and Botanical II
Date Published: 04/24/2017
Desc: Huang Lian Su Herbal Supplement Tablets
54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017
Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets
54 K - - -- Herbal & Botanicals(other than teas) II
Date Published: 04/24/2017
Desc: Huang Lian Su Herbal Supplement Tablets
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017
Desc: Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 04/24/2017
Desc: Huang Lian Su Herbal Supplement Tablets
Lanzhou Foci Pharmaceutical Co., Ltd.
Date Published : 07/14/2025
No. 2289 Huashan Rd. , Lanzhou New Area
, Lanzhou,
Gansu CHINA
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Xiao Chai Hu Tang Wan (Liver Smooth)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Huo Xiang Zheng Qi Teapills (Huo Xiang Zheng Qi Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Liu Jun Wan (Digestion Ease)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Bao He Teapills (Bao He Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Yang Wei Wan
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Huo Xiang Zheng Qi Wan (Strengthen Dampness)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Major Bupleurum Teapills (Da Chai Hu Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Bao He Wan (Strengthen Digestion)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Yang Wei Wan (Digestive Aid)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 A - - 99 Vitamin, N.E.C.
Date Published: 07/14/2025
Desc: Clear Mountain Air Teapills (Ding Chuan Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Huo Xiang Zheng Qi Teapills (Huo Xiang Zheng Qi Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Xiao Chai Hu Tang Wan (Liver Smooth)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Yang Wei Wan (Digestive Aid)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Bao He Wan (Strengthen Digestion)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Huo Xiang Zheng Qi Wan (Strengthen Dampness)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Clear Mountain Air Teapills (Ding Chuan Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Liu Jun Wan (Digestion Ease)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Yang Wei Wan
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Bao He Teapills (Bao He Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 07/14/2025
Desc: Major Bupleurum Teapills (Da Chai Hu Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Huo Xiang Zheng Qi Wan (Strengthen Dampness)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Major Bupleurum Teapills (Da Chai Hu Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Xiao Chai Hu Tang Wan (Liver Smooth)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Clear Mountain Air Teapills (Ding Chuan Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Liu Jun Wan (Digestion Ease)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Yang Wei Wan
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Xiang Sha Yang Wei Wan (Digestive Aid)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Huo Xiang Zheng Qi Teapills (Huo Xiang Zheng Qi Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Bao He Teapills (Bao He Wan)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/14/2025
Desc: Bao He Wan (Strengthen Digestion)
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). It appears the dietary supplement products that the firm manufactures are adulterated within the meaning of section(s) 402(g)(1) of the Act [21 U.S.C. 342(g)(1)].
Life Rising (Tianjin) Natural Product R&D Center LTD
Date Published : 12/13/2016
# 12 Luyuan Street
, Wuqing,
Tianjin CHINA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
04 - - - -- Macaroni/Noodle Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
07 - - - -- Snack Food Items
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
12 - - - -- Cheese/Cheese Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
13 - - - -- Ice Cream and related Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
15 - - - -- Eggs/Egg Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
16 - - - -- Fishery/Seafood Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
17 - - - -- Meats, Meat Products and Poultry
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
18 - - - -- Vegetable Protein Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
20 - - - -- Fruit/Fruit Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
21 - - - -- Fruit/Fruit Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
22 - - - -- Fruit/Fruit Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
23 - - - -- Nuts/Edible Seeds
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
24 - - - -- Vegetables/Vegetable Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
25 - - - -- Vegetables/Vegetable Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
26 - - - -- Vegetable Oils
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
27 - - - -- Dressing/Condiments
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
28 - - - -- Spices, Flavors And Salts
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
31 - - - -- Coffee/Tea
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
32 - - - -- Alcoholic Beverages
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
38 - - - -- Soups
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
39 - - - -- Prepared Salad Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 A - - -- Baked Goods (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 B - - -- Cereal (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 D - - -- Veg (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 J - - -- Egg Prod (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 K - - -- Pudding/Custard (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 X - - -- Market Basket Sampling
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
40 Y - - -- Baby Food N.E.C.
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 B - - -- Milled Edible Insect Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 C - - -- Edible Insect Bars
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 D - - -- Edible Insect Bakery Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 G - - -- Edible Insect Capsules
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 I - - -- Edible Insect Jerky
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 K - - -- Edible Insect Oils
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 L - - -- Edible Insect Smoothies
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 M - - -- Edible Insect Soups
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 O - - -- Edible Insect Beverages
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 Q - - -- Edible Insect Salts and Spices
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
42 R - - -- Edible Insect Products N.E.C.
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
52 B - - 06 Corn Husks (Food Related)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
52 B - - 07 Snail Shells (Food Related)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
52 B - - 12 Non-Edible Bird's Nest
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
52 D - - -- Live Animals
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 12/13/2016
Notes: All Dietary Supplements;CFSAN recommended placing firm on IA due to
violative foreign inspection
Shantou Olive Branch Biotechnology Co. Ltd.
Date Published : 04/17/2020
No. 94 Chaoshan Road , Jinping District
, Shantou,
Guangdong CHINA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/17/2020
Desc: Di Gu Pi San Herbal Dietary Supplement
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 04/17/2020
Desc: Zhen Wu Tang Herbal Dietary Supplement
Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 01/13/2017
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao
, Tianjin,
Tianjin CHINA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
04 - - - -- Macaroni/Noodle Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
07 - - - -- Snack Food Items
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
12 - - - -- Cheese/Cheese Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
13 - - - -- Ice Cream and related Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
15 - - - -- Eggs/Egg Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
16 - - - -- Fishery/Seafood Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
17 - - - -- Meats, Meat Products and Poultry
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
18 - - - -- Vegetable Protein Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
20 - - - -- Fruit/Fruit Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
21 - - - -- Fruit/Fruit Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
22 - - - -- Fruit/Fruit Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
23 - - - -- Nuts/Edible Seeds
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
24 - - - -- Vegetables/Vegetable Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
25 - - - -- Vegetables/Vegetable Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
26 - - - -- Vegetable Oils
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
27 - - - -- Dressing/Condiments
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
28 - - - -- Spices, Flavors And Salts
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
31 - - - -- Coffee/Tea
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
32 - - - -- Alcoholic Beverages
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
38 - - - -- Soups
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
39 - - - -- Prepared Salad Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 A - - -- Baked Goods (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 B - - -- Cereal (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 D - - -- Veg (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 J - - -- Egg Prod (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 K - - -- Pudding/Custard (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 X - - -- Market Basket Sampling
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 Y - - -- Baby Food N.E.C.
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 B - - -- Milled Edible Insect Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 C - - -- Edible Insect Bars
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 D - - -- Edible Insect Bakery Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 G - - -- Edible Insect Capsules
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 I - - -- Edible Insect Jerky
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 K - - -- Edible Insect Oils
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 L - - -- Edible Insect Smoothies
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 M - - -- Edible Insect Soups
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 O - - -- Edible Insect Beverages
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 Q - - -- Edible Insect Salts and Spices
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 R - - -- Edible Insect Products N.E.C.
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 06 Corn Husks (Food Related)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 07 Snail Shells (Food Related)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 12 Non-Edible Bird's Nest
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 D - - -- Live Animals
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
Tianjin Medicines & Health Products Import & Export Corp.
Date Published : 01/13/2017
Hai Tai Information Square, Hi-Tech Indu , Building C 5th Floor; NO. 8 Huatiandao
, Tianjin,
Tianjin CHINA
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
04 - - - -- Macaroni/Noodle Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
07 - - - -- Snack Food Items
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
12 - - - -- Cheese/Cheese Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
13 - - - -- Ice Cream and related Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
15 - - - -- Eggs/Egg Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
16 - - - -- Fishery/Seafood Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
17 - - - -- Meats, Meat Products and Poultry
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
18 - - - -- Vegetable Protein Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
20 - - - -- Fruit/Fruit Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
21 - - - -- Fruit/Fruit Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
22 - - - -- Fruit/Fruit Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
23 - - - -- Nuts/Edible Seeds
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
24 - - - -- Vegetables/Vegetable Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
25 - - - -- Vegetables/Vegetable Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
26 - - - -- Vegetable Oils
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
27 - - - -- Dressing/Condiments
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
28 - - - -- Spices, Flavors And Salts
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
31 - - - -- Coffee/Tea
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
32 - - - -- Alcoholic Beverages
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
38 - - - -- Soups
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
39 - - - -- Prepared Salad Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 A - - -- Baked Goods (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 B - - -- Cereal (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 D - - -- Veg (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 J - - -- Egg Prod (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 K - - -- Pudding/Custard (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 X - - -- Market Basket Sampling
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
40 Y - - -- Baby Food N.E.C.
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 B - - -- Milled Edible Insect Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 C - - -- Edible Insect Bars
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 D - - -- Edible Insect Bakery Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 G - - -- Edible Insect Capsules
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 I - - -- Edible Insect Jerky
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 K - - -- Edible Insect Oils
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 L - - -- Edible Insect Smoothies
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 M - - -- Edible Insect Soups
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 O - - -- Edible Insect Beverages
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 Q - - -- Edible Insect Salts and Spices
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
42 R - - -- Edible Insect Products N.E.C.
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 06 Corn Husks (Food Related)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 07 Snail Shells (Food Related)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 B - - 12 Non-Edible Bird's Nest
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
52 D - - -- Live Animals
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 01/13/2017
Notes: All Dietary Supplements;The FDA inspected the above referenced foreign
dietary supplement distributor on September 20-23, 2016 and found serious
deviations of the FDA's Current Good Manufacturing Practices (cGMP) in
Manufacturing, Packaging, Labeling, or Holding Operations for Dietary
Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part
111).
CZECH REPUBLIC
UNIREGEN spol s.r.o.
Date Published : 09/11/2025
Na Brzdach 72
, Nachod,
Kralovehradecky CZECH REPUBLIC
54 G - - 01 Bovine (Cow, Etc.) (Animal By-Products and Extracts)
Date Published: 09/11/2025
Desc: Imuregen Glucan (Capsules) products
Notes: Based on FDA’s inspectional findings, the firm’s Imuregen (liquid), Imuregen+ (capsules), and Imuregen glucan+ (capsules) products are adulterated within the meaning of section 402(g)(1). Specific violations include: 21 CFR 111.75(c) – failure to verify that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, 21 CFR 11.75(a)(1)(i) – failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in manufacturing, and 21 CFR 189.5(c)(1) – failure to establish and maintain records to demonstrate that their products do not contain cattle materials that are free from BSE.
54 G - - 01 Bovine (Cow, Etc.) (Animal By-Products and Extracts)
Date Published: 09/11/2025
Desc: Imuregen (Capsules) products
Notes: Based on FDA’s inspectional findings, the firm’s Imuregen (liquid), Imuregen+ (capsules), and Imuregen glucan+ (capsules) products are adulterated within the meaning of section 402(g)(1). Specific violations include: 21 CFR 111.75(c) – failure to verify that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, 21 CFR 11.75(a)(1)(i) – failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in manufacturing, and 21 CFR 189.5(c)(1) – failure to establish and maintain records to demonstrate that their products do not contain cattle materials that are free from BSE.
54 G - - 01 Bovine (Cow, Etc.) (Animal By-Products and Extracts)
Date Published: 09/11/2025
Desc: Imuregen (liquid) products
Notes: Based on FDA’s inspectional findings, the firm’s Imuregen (liquid), Imuregen+ (capsules), and Imuregen glucan+ (capsules) products are adulterated within the meaning of section 402(g)(1). Specific violations include: 21 CFR 111.75(c) – failure to verify that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, 21 CFR 11.75(a)(1)(i) – failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in manufacturing, and 21 CFR 189.5(c)(1) – failure to establish and maintain records to demonstrate that their products do not contain cattle materials that are free from BSE.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/11/2025
Desc: Imuregen Glucan (Capsules) products
Notes: Based on FDA’s inspectional findings, the firm’s Imuregen (liquid), Imuregen+ (capsules), and Imuregen glucan+ (capsules) products are adulterated within the meaning of section 402(g)(1). Specific violations include: 21 CFR 111.75(c) – failure to verify that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, 21 CFR 11.75(a)(1)(i) – failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in manufacturing, and 21 CFR 189.5(c)(1) – failure to establish and maintain records to demonstrate that their products do not contain cattle materials that are free from BSE.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/11/2025
Desc: Imuregen (Capsules) products
Notes: Based on FDA’s inspectional findings, the firm’s Imuregen (liquid), Imuregen+ (capsules), and Imuregen glucan+ (capsules) products are adulterated within the meaning of section 402(g)(1). Specific violations include: 21 CFR 111.75(c) – failure to verify that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, 21 CFR 11.75(a)(1)(i) – failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in manufacturing, and 21 CFR 189.5(c)(1) – failure to establish and maintain records to demonstrate that their products do not contain cattle materials that are free from BSE.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 09/11/2025
Desc: Imuregen (liquid) products
Notes: Based on FDA’s inspectional findings, the firm’s Imuregen (liquid), Imuregen+ (capsules), and Imuregen glucan+ (capsules) products are adulterated within the meaning of section 402(g)(1). Specific violations include: 21 CFR 111.75(c) – failure to verify that the finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, 21 CFR 11.75(a)(1)(i) – failure to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use in manufacturing, and 21 CFR 189.5(c)(1) – failure to establish and maintain records to demonstrate that their products do not contain cattle materials that are free from BSE.
DOMINICAN REPUBLIC (THE)
Alopecil Corporation, S.R.L.
Date Published : 11/10/2016
Autopista 30 De Mayo No. 111 , Haina, D.N.
, Santo Domingo,
DO-01 DOMINICAN REPUBLIC (THE)
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016
Desc: Punch Natural
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016
Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 11/10/2016
Desc: Balsamic Honey Syrup
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016
Desc: Punch Natural
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016
Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/10/2016
Desc: Balsamic Honey Syrup
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016
Desc: Watercress and Onion Radish Honey Syrup (Herro y Cebolla)
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016
Desc: Punch Natural
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/10/2016
Desc: Balsamic Honey Syrup
Notes: The FDA inspected the above referenced foreign food manufacturing facility on
June 6-8; 2016 and found serious deviations of the FDA's Current Good
Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding
Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part
111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it
appears the firm's Balsamic Honey Syrup; Punch Natural; and Watercress and
Onion Radish Honey Syrup products are adulterated within the meaning of section
402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)
(1)] in that they have been prepared; packed; or held under conditions that do
not comply with the cGMP regulations for dietary supplements
FIJI
Ace Kava Exporters
Date Published : 07/17/2020
Wailoaloa , Nadi Back Road
, Nadi,
FIJI
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 07/17/2020
Notes: All Dietary Supplements
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 07/17/2020
Notes: All Dietary Supplements
04 - - - -- Macaroni/Noodle Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 07/17/2020
Notes: All Dietary Supplements
07 - - - -- Snack Food Items
Date Published: 07/17/2020
Notes: All Dietary Supplements
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
12 - - - -- Cheese/Cheese Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
13 - - - -- Ice Cream and related Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
15 - - - -- Eggs/Egg Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
16 - - - -- Fishery/Seafood Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
17 - - - -- Meats, Meat Products and Poultry
Date Published: 07/17/2020
Notes: All Dietary Supplements
18 - - - -- Vegetable Protein Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
20 - - - -- Fruit/Fruit Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
21 - - - -- Fruit/Fruit Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
22 - - - -- Fruit/Fruit Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
23 - - - -- Nuts/Edible Seeds
Date Published: 07/17/2020
Notes: All Dietary Supplements
24 - - - -- Vegetables/Vegetable Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
25 - - - -- Vegetables/Vegetable Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
26 - - - -- Vegetable Oils
Date Published: 07/17/2020
Notes: All Dietary Supplements
27 - - - -- Dressing/Condiments
Date Published: 07/17/2020
Notes: All Dietary Supplements
28 - - - -- Spices, Flavors And Salts
Date Published: 07/17/2020
Notes: All Dietary Supplements
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 07/17/2020
Notes: All Dietary Supplements
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 07/17/2020
Notes: All Dietary Supplements
31 - - - -- Coffee/Tea
Date Published: 07/17/2020
Notes: All Dietary Supplements
31 - - - -- Coffee/Tea
Date Published: 07/17/2020
Desc: All Dietary Supplements
32 - - - -- Alcoholic Beverages
Date Published: 07/17/2020
Notes: All Dietary Supplements
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 07/17/2020
Notes: All Dietary Supplements
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 07/17/2020
Notes: All Dietary Supplements
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 07/17/2020
Notes: All Dietary Supplements
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 07/17/2020
Notes: All Dietary Supplements
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 07/17/2020
Notes: All Dietary Supplements
38 - - - -- Soups
Date Published: 07/17/2020
Notes: All Dietary Supplements
39 - - - -- Prepared Salad Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 A - - -- Baked Goods (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 B - - -- Cereal (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 D - - -- Veg (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 J - - -- Egg Prod (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 K - - -- Pudding/Custard (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 X - - -- Market Basket Sampling
Date Published: 07/17/2020
Notes: All Dietary Supplements
40 Y - - -- Baby Food N.E.C.
Date Published: 07/17/2020
Notes: All Dietary Supplements
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 B - - -- Milled Edible Insect Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 C - - -- Edible Insect Bars
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 D - - -- Edible Insect Bakery Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 G - - -- Edible Insect Capsules
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 I - - -- Edible Insect Jerky
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 K - - -- Edible Insect Oils
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 L - - -- Edible Insect Smoothies
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 M - - -- Edible Insect Soups
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 O - - -- Edible Insect Beverages
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 Q - - -- Edible Insect Salts and Spices
Date Published: 07/17/2020
Notes: All Dietary Supplements
42 R - - -- Edible Insect Products N.E.C.
Date Published: 07/17/2020
Notes: All Dietary Supplements
52 B - - 06 Corn Husks (Food Related)
Date Published: 07/17/2020
Notes: All Dietary Supplements
52 B - - 07 Snail Shells (Food Related)
Date Published: 07/17/2020
Notes: All Dietary Supplements
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 07/17/2020
Notes: All Dietary Supplements
52 B - - 12 Non-Edible Bird's Nest
Date Published: 07/17/2020
Notes: All Dietary Supplements
52 D - - -- Live Animals
Date Published: 07/17/2020
Notes: All Dietary Supplements
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/17/2020
Notes: All Dietary Supplements
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 07/17/2020
Desc: All Dietary Supplements
DATELINE KAVA
Date Published : 06/30/2023
Lot 14 , Auto City, Raiwaqa
, Suva,
Central FIJI
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/30/2023
Desc: All Dietary Supplement Products
Notes: All Dietary Supplement Products, including the Best Fiji Kava Product.
Frezco Beverages
Date Published : 11/03/2022
Lot 20 , Waqarda Industrial Sub-Division
, Nadi,
None of the above FIJI
21 V - - 43 Noni, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars
Date Published: 11/03/2022
Desc: NONI JUICE
Notes: GMP deviations noted during FDA foreign inspection of firm
54 F - - 93 Noni (Herbal & Botanicals, not Teas)
Date Published: 11/03/2022
Desc: NONI JUICE
Notes: GMP deviations noted during FDA foreign inspection
Vinod Maharaj Kava Exports PTE LTD
Date Published : 08/11/2023
Lot 11 , Vusiya Rd
, Nausori,
Central FIJI
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/11/2023
Desc: All Dietary Supplement Products
GERMANY
Bio-Gen Milchserum Marketing GmbH
Date Published : 04/15/2025
Graf-Von-Zeppelin-Str. 2-4
, Montabaur,
Rhineland-Palatinate GERMANY
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 04/15/2025
Desc: Hair Plus
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 04/15/2025
Desc: Q10 Plus
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 04/15/2025
Desc: Hair Plus
54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 04/15/2025
Desc: Hair Plus
54 H - - 05 Omega-3 (Fats and Lipid Substances)
Date Published: 04/15/2025
Desc: Q10 Plus
54 Y - - 08 Coenzyme Q10 (Vit/Min/Protein/Unconventional Dietary Spec for Human/Animal, N.E.C.)
Date Published: 04/15/2025
Desc: Q10 Plus
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 04/15/2025
Desc: Hair Plus
PLANTAFOOD MEDICAL GMBH
Date Published : 09/04/2019
Am Sportplatz 3
, Leiningen,
Rhineland-Palatinate GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Sugarit
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Sleep Food
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Repair Food
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Skin Food
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Cinamit
Plantafood Medical Gmbh
Date Published : 09/04/2019
Horst-Uhlig-Str. 3
, Laudert,
Rhineland-Palatinate GERMANY
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Skin Food
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Repair Food
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Cinamit
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Sugarit
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 09/04/2019
Desc: Sleep Food
INDIA
Chakrapani Ayurveda Clinic & Research Center
Date Published : 06/08/2023
8 Diamond Hill , Shanti Path; Tulsi Circle
, Jaipur,
Rajasthan INDIA
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Kanchanar Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Shwas (Asthma help) Herbal Tea
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Yograj Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Medohar (Obesity Help) Herbal Tea
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Mansyadi
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Gokshuradi Guggul
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Kaishore Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Triphala Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Mahasudarshan
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Sanshamani
Notes: GMP deviations noted during FDA foreign inspection of the firm.
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/08/2023
Desc: Avipattikar
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Kaishore Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Yograj Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Kanchanar Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Triphala Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Shwas (Asthma help) Herbal Tea
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Medohar (Obesity Help) Herbal Tea
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Mansyadi
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Mahasudarshan
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Avipattikar
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Sanshamani
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/08/2023
Desc: Gokshuradi Guggul
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Kanchanar Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Mahasudarshan
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Yograj Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Medohar (Obesity Help) Herbal Tea
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Triphala Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Kaishore Guggul Powder
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Shwas (Asthma help) Herbal Tea
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Gokshuradi Guggul
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Avipattikar
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Sanshamani
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/08/2023
Desc: Mansyadi
Notes: GMP deviations noted during FDA foreign inspection of the firm.
FALCON SYSTEM OF AYURVEDIC PRODUCTS
Date Published : 04/11/2025
Plot No 984, 5th Cross,Kiadb Industrial Area , Auto Nagar
, Belgaum,
INDIA
41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners
Date Published: 04/11/2025
Desc: All Dietary Supplement Products
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.12(c), 21 CFR 111.20(c), 21 CFR 111.27(d)(6), 21 CFR 111.55, 21 CFR 111.65, and 21 CFR 111.70, indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/11/2025
Desc: All Dietary Supplement Products
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.12(c), 21 CFR 111.20(c), 21 CFR 111.27(d)(6), 21 CFR 111.55, 21 CFR 111.65, and 21 CFR 111.70, indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
Goodcare Pharma Pvt. Ltd.
Date Published : 11/08/2023
VI/VII Bagi, Bishnupur , South Twenty Four Parganas
, West Bengal,
INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Safed Musali (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Bhumi Amla (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Arthplus (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Kaishore Guggulu (Goodcare Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 11/08/2023
Desc: Moringa (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Bhumi Amla (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Kaishore Guggulu (Goodcare Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Safed Musali (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Arthplus (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
Goodcare Pharma Pvt. Ltd.
Date Published : 11/08/2023
VI/VII Bagi, Bishnupur , South Twenty Four Parganas
, West Bengal,
INDIA
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Bhumi Amla (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Arthplus (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Kaishore Guggulu (Goodcare Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 11/08/2023
Desc: Safed Musali (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
54 K - - 10 Moringa Oleifera (Herbal and Botanical (not Teas II) contd
Date Published: 11/08/2023
Desc: Moringa (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Kaishore Guggulu (Goodcare Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Bhumi Amla (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Arthplus (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 11/08/2023
Desc: Safed Musali (Leaf Care Brand)
Notes: GMP deviations noted during FDA foreign inspection of the firm.
Khandige Organic Health Products Pvt Ltd
Date Published : 03/27/2025
Off Kanakapura Road , No - 30 Pipe Line Road, Near Bibi Fathima School
, Bengaluru,
Karnataka INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 03/27/2025
Desc: All Dietary Supplement Products
M/S Svatv Herbs India Pvt. Ltd.
Date Published : 08/25/2025
1st Floor , B - 25
, New Delhi,
Delhi INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/25/2025
Desc: Svatv %u2013 Giloy Powder
Notes: All Dietary Supplement products
FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specific violations of 21 CFR 111.103, 21 CFR 111.453, and 21 CFR 111.503, indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/25/2025
Desc: Svatv %u2013 Beet Root Powder
Notes: All Dietary Supplement products
FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specific violations of 21 CFR 111.103, 21 CFR 111.453, and 21 CFR 111.503, indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/25/2025
Desc: Svatv %u2013 Shatavari Powder
Notes: All Dietary Supplement products
FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specific violations of 21 CFR 111.103, 21 CFR 111.453, and 21 CFR 111.503, indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/25/2025
Desc: Svatv %u2013 Bhumi Amla Powder
Notes: All Dietary Supplement products
FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specific violations of 21 CFR 111.103, 21 CFR 111.453, and 21 CFR 111.503, indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
Patanjali Ayurved Limited
Date Published : 04/06/2015
D - 38
, Haridwar,
Uttarakhand INDIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/06/2015
Notes: Product Description /Product Code(s):
All dietary supplements
Notes:
FDA inspection found serious deviations of the cGMP.
Planet Ayurveda Private Limited
Date Published : 06/04/2025
Plot No - 627 Sector 82 - Mohali , Planet Ayurveda
, Sas Nagar (Mohali),
Punjab INDIA
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Livo Plan syrup
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Stress support capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Brahni powder (capsules)
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Arjuna powder and tea
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Arjuna Churna powder and tea
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Nature-Amino powder blend
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Motion Stop tablets
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/04/2025
Desc: Stress capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 06/04/2025
Desc: Ashwaganda root capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 E - - 94 Ashwagandha (Herbal & Botanical Teas)
Date Published: 06/04/2025
Desc: Arjuna Churna powder and tea
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 F - - 94 Ashwagandha (Herbal & Botanicals, not Teas)
Date Published: 06/04/2025
Desc: Ashwaganda root capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C.
Date Published: 06/04/2025
Desc: Ashwaganda root capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Brahni powder (capsules)
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Arjuna powder and tea
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Stress capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Nature-Amino powder blend
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Motion Stop tablets
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Stress support capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/04/2025
Desc: Livo Plan syrup
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 06/04/2025
Desc: Stress support capsules
Notes: FDA inspected the foreign food manufacturing facility from December 12, 2024 through January 22, 2025 and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
JAMAICA
Delightful Gardens Enterprise Limited
Date Published : 06/11/2020
1027 Delightful District Po
, Junction,
Saint Elizabeth JAMAICA
30 G - - 99 Beverage Base of Non-Fruit Origin, Liquid, N.E.C.
Date Published: 06/11/2020
Desc: All Dietary Supplement Products
41 Y - - 99 Dietary Conventional Foods, N.E.C.
Date Published: 06/11/2020
Desc: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/11/2020
Notes: All Dietary Supplement Products
JAPAN
FCC Horiuchi Co., Ltd.
Date Published : 11/18/2024
1 Chome 6-3 , Higashiaikawa
, Kurume,
Fukuoka JAPAN
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
04 - - - -- Macaroni/Noodle Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
07 - - - -- Snack Food Items
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
12 - - - -- Cheese/Cheese Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
13 - - - -- Ice Cream and related Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
15 - - - -- Eggs/Egg Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
16 - - - -- Fishery/Seafood Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
17 - - - -- Meats, Meat Products and Poultry
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
18 - - - -- Vegetable Protein Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
20 - - - -- Fruit/Fruit Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
21 - - - -- Fruit/Fruit Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
22 - - - -- Fruit/Fruit Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
23 - - - -- Nuts/Edible Seeds
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
24 - - - -- Vegetables/Vegetable Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
25 - - - -- Vegetables/Vegetable Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
26 - - - -- Vegetable Oils
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
27 - - - -- Dressing/Condiments
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
28 - - - -- Spices, Flavors And Salts
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
31 - - - -- Coffee/Tea
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
32 - - - -- Alcoholic Beverages
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
38 - - - -- Soups
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
39 - - - -- Prepared Salad Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 A - - -- Baked Goods (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 B - - -- Cereal (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 D - - -- Veg (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 J - - -- Egg Prod (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 K - - -- Pudding/Custard (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 X - - -- Market Basket Sampling
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
40 Y - - -- Baby Food N.E.C.
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 B - - -- Milled Edible Insect Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 C - - -- Edible Insect Bars
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 D - - -- Edible Insect Bakery Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 G - - -- Edible Insect Capsules
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 I - - -- Edible Insect Jerky
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 K - - -- Edible Insect Oils
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 L - - -- Edible Insect Smoothies
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 M - - -- Edible Insect Soups
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 O - - -- Edible Insect Beverages
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 Q - - -- Edible Insect Salts and Spices
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
42 R - - -- Edible Insect Products N.E.C.
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
52 B - - 06 Corn Husks (Food Related)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
52 B - - 07 Snail Shells (Food Related)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
52 B - - 12 Non-Edible Bird's Nest
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
52 D - - -- Live Animals
Date Published: 11/18/2024
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/18/2024
Desc: All Dietary Supplement Products
NIKKO YAKUHIN KOGYO CO.,LTD.
Date Published : 03/21/2017
2 Chome , Hara; Tenpaku
, Nagoya,
Aichi JAPAN
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/21/2017
Desc: Pure Gold Collagen
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5, 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111, it appears the "Pure Gold Collagen" product is adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that it has been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements.
Sunsho Pharmaceutical Co., Ltd.
Date Published : 08/06/2025
1468 , Atsuhara
, Fuji,
Shizuoka JAPAN
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/06/2025
Desc: All Dietary Supplement Products
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specific violations of 21 CFR 111.70(e) and 21 CFR 111.320(b) indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
Sunsho Pharmaceutical Co., Ltd.
Date Published : 08/06/2025
4527-7 , Obuchi
, Fuji,
Shizuoka JAPAN
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/06/2025
Desc: All Dietary Supplement Products
Notes: FDA inspected the manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specific violations of 21 CFR 111.70(e) and 21 CFR 111.320(b) indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
MALAYSIA
Phyto Science
Date Published : 08/30/2017
9 PT Jalan 9/8
, Bandar Baru Bangi,
Selangor MALAYSIA
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 08/30/2017
Desc: Apple Stem Cell And Grape Stem Cell Supplement Powder
MEXICO
ARMONIA EN ENVASADO Y NUTRICION SA DE CV
Date Published : 03/06/2015
Calzada Atlas Norte 535 , Fracc. Club De Golf Atlas, Tlaquepaque
, Tlaquepaque,
Jalisco MEXICO
54 I - - 99 Fiber, N.E.C.
Date Published: 03/06/2015
Desc: Green Juice (Jugo Verde)
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 I - - 99 Fiber, N.E.C.
Date Published: 03/06/2015
Desc: Apple Fiber
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 I - - 99 Fiber, N.E.C.
Date Published: 03/06/2015
Desc: Forte Concentrated Fiber
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015
Desc: Apple Fiber
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015
Desc: Forte Concentrated Fiber
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015
Desc: Colageno
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015
Desc: Green Juice (Jugo Verde)
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/06/2015
Desc: Canary Seed Milk
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21 CFR Part 111.)
Apicola de Allende, S.A. de C.V.
Date Published : 04/24/2017
Lerdo De Tejada No. 202 Ote. , Col. Centro Seccion
, Allende,
Nuevo Leon MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017
Desc: Propolis Liquid Extract Drops
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5; 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it appears the "Propolis Liquid Extract Drops" product is adulterated within the meaning of section 402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that it has been prepared; packed; or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017
Desc: Propolis Capsules
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5; 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it appears the "Propolis Capsules" product is adulterated within the meaning of section 402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that it has been prepared; packed; or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017
Desc: EspectiBron
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5; 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it appears the "EspectiBron" product is adulterated within the meaning of section 402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that it has been prepared; packed; or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017
Desc: Royal Jelly
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5; 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it appears the "Royal Jelly" product is adulterated within the meaning of section 402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that it has been prepared; packed; or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017
Desc: Bee Pollen
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5; 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it appears the "Bee Pollen" product is adulterated within the meaning of section 402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that it has been prepared; packed; or held under conditions that do not comply with the cGMP regulations for dietary supplements.
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/24/2017
Desc: Royal Jelly Capsules
Notes: The FDA inspected the above referenced foreign food manufacturing facility on August 3-5; 2016 and found serious deviations of the FDA's Current Good Manufacturing Practices (cGMP) in Manufacturing; Packaging; Labeling; or Holding Operations for Dietary Supplements; Title 21; Code of Federal Regulations; Part 111 (21 CFR Part 111). Based on the firm's failure to comply with 21 CFR 111; it appears the "Royal Jelly Capsules" product is adulterated within the meaning of section 402(g)(1) of the Federal Food; Drug; and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that it has been prepared; packed; or held under conditions that do not comply with the cGMP regulations for dietary supplements.
Dibar Nutricional S. de R.L. de C.V.
Date Published : 11/24/2021
Mezquite 18 , Morelia
, Puerto De Buenavista (Lazaro Cardenas),
Michoacan de Ocampo MEXICO
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 11/24/2021
Notes: All Dietary Supplements
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 11/24/2021
Notes: All Dietary Supplements
04 - - - -- Macaroni/Noodle Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 11/24/2021
Notes: All Dietary Supplements
07 - - - -- Snack Food Items
Date Published: 11/24/2021
Notes: All Dietary Supplements
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
12 - - - -- Cheese/Cheese Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
13 - - - -- Ice Cream and related Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
15 - - - -- Eggs/Egg Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
16 - - - -- Fishery/Seafood Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
17 - - - -- Meats, Meat Products and Poultry
Date Published: 11/24/2021
Notes: All Dietary Supplements
18 - - - -- Vegetable Protein Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
20 - - - -- Fruit/Fruit Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
21 - - - -- Fruit/Fruit Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
22 - - - -- Fruit/Fruit Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
23 - - - -- Nuts/Edible Seeds
Date Published: 11/24/2021
Notes: All Dietary Supplements
24 - - - -- Vegetables/Vegetable Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
25 - - - -- Vegetables/Vegetable Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
26 - - - -- Vegetable Oils
Date Published: 11/24/2021
Notes: All Dietary Supplements
27 - - - -- Dressing/Condiments
Date Published: 11/24/2021
Notes: All Dietary Supplements
28 - - - -- Spices, Flavors And Salts
Date Published: 11/24/2021
Notes: All Dietary Supplements
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 11/24/2021
Notes: All Dietary Supplements
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 11/24/2021
Notes: All Dietary Supplements
31 - - - -- Coffee/Tea
Date Published: 11/24/2021
Notes: All Dietary Supplements
32 - - - -- Alcoholic Beverages
Date Published: 11/24/2021
Notes: All Dietary Supplements
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 11/24/2021
Notes: All Dietary Supplements
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 11/24/2021
Notes: All Dietary Supplements
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 11/24/2021
Notes: All Dietary Supplements
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 11/24/2021
Notes: All Dietary Supplements
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 11/24/2021
Notes: All Dietary Supplements
38 - - - -- Soups
Date Published: 11/24/2021
Notes: All Dietary Supplements
39 - - - -- Prepared Salad Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 A - - -- Baked Goods (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 B - - -- Cereal (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 D - - -- Veg (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 J - - -- Egg Prod (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 K - - -- Pudding/Custard (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 X - - -- Market Basket Sampling
Date Published: 11/24/2021
Notes: All Dietary Supplements
40 Y - - -- Baby Food N.E.C.
Date Published: 11/24/2021
Notes: All Dietary Supplements
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 B - - -- Milled Edible Insect Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 C - - -- Edible Insect Bars
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 D - - -- Edible Insect Bakery Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 G - - -- Edible Insect Capsules
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 I - - -- Edible Insect Jerky
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 K - - -- Edible Insect Oils
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 L - - -- Edible Insect Smoothies
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 M - - -- Edible Insect Soups
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 O - - -- Edible Insect Beverages
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 Q - - -- Edible Insect Salts and Spices
Date Published: 11/24/2021
Notes: All Dietary Supplements
42 R - - -- Edible Insect Products N.E.C.
Date Published: 11/24/2021
Notes: All Dietary Supplements
52 B - - 06 Corn Husks (Food Related)
Date Published: 11/24/2021
Notes: All Dietary Supplements
52 B - - 07 Snail Shells (Food Related)
Date Published: 11/24/2021
Notes: All Dietary Supplements
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 11/24/2021
Notes: All Dietary Supplements
52 B - - 12 Non-Edible Bird's Nest
Date Published: 11/24/2021
Notes: All Dietary Supplements
52 D - - -- Live Animals
Date Published: 11/24/2021
Notes: All Dietary Supplements
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/24/2021
Notes: All Dietary Supplements
Healthy People Labs S de RL de CV
Date Published : 08/19/2015
PROL. ALVARO OBREGON # 961 , COL. LOS HOYOS
, Irapuato,
Guanajuato MEXICO
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/19/2015
Desc: Healthy Flex
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/19/2015
Desc: Rena Extreme
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2015
Desc: Healthy Flex
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 08/19/2015
Desc: Rena Extreme
Herbal Solution's Health S.A. de C.V.
Date Published : 03/18/2019
Calzada Insurgentes Poniente No. 322 , Barrio Barrio De Santa Anita, Irapuato
, Irapuato,
Guanajuato MEXICO
54 F - - 47 Garcinia cambogia (Herbal & Botanicals, not Teas)
Date Published: 03/18/2019
Desc: Prosmen Dietary Supplement
54 F - - 47 Garcinia cambogia (Herbal & Botanicals, not Teas)
Date Published: 03/18/2019
Desc: Active CL Dietary Supplement
54 F - - 84 Milk Thistle (Herbal & Botanical other than teas)
Date Published: 03/18/2019
Desc: HP Liv Dietary Supplement
54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/18/2019
Desc: Active CL Dietary Supplement
54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/18/2019
Desc: HP Liv Dietary Supplement
54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/18/2019
Desc: Prosmen Dietary Supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2019
Desc: HP Liv Dietary Supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2019
Desc: Active CL Dietary Supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2019
Desc: Prosmen Dietary Supplement
Herbal Solutions Health, S.A. de C.V
Date Published : 03/18/2019
Guadalupe de Paso Blanco Lot. 10
, Irapuato,
Guanajuato MEXICO
54 F - - 47 Garcinia cambogia (Herbal & Botanicals, not Teas)
Date Published: 03/18/2019
Desc: Prosmen Dietary Supplement
54 F - - 47 Garcinia cambogia (Herbal & Botanicals, not Teas)
Date Published: 03/18/2019
Desc: Active CL Dietary Supplement
54 F - - 84 Milk Thistle (Herbal & Botanical other than teas)
Date Published: 03/18/2019
Desc: HP Liv Dietary Supplement
54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/18/2019
Desc: Prosmen Dietary Supplement
54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/18/2019
Desc: Active CL Dietary Supplement
54 K C A -- Herbal & Botanicals(other than teas) II, Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 03/18/2019
Desc: HP Liv Dietary Supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2019
Desc: Active CL Dietary Supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2019
Desc: HP Liv Dietary Supplement
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 03/18/2019
Desc: Prosmen Dietary Supplement
Herbolaris Internacional
Date Published : 12/17/2014
Calle Los Robles 122 , Col. Parques De Zapopan, Zapopan
, Zapopan,
Jalisco MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/17/2014
Desc: XYN-S Syrup
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21CFR Part 111)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/17/2014
Desc: Nutry Light Shake
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21CFR Part 111)
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 12/17/2014
Desc: Mi Desayuno Diario (My Daily Breakfast)
Notes: Problem(s); FDA inspection of the firm found serious deviations of the Dietary Supplement GMPs (21CFR Part 111)
Laboratorio Mas Natural S. de R.L. de C.V.
Date Published : 06/17/2015
Camino a Serrano No. 846 , Col. ZONA CENTRO
, Irapuato,
Guanajuato MEXICO
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
04 - - - -- Macaroni/Noodle Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
07 - - - -- Snack Food Items
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
12 - - - -- Cheese/Cheese Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
13 - - - -- Ice Cream and related Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
15 - - - -- Eggs/Egg Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
16 - - - -- Fishery/Seafood Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
17 - - - -- Meats, Meat Products and Poultry
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
18 - - - -- Vegetable Protein Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
20 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
21 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
22 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
23 - - - -- Nuts/Edible Seeds
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
24 - - - -- Vegetables/Vegetable Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
25 - - - -- Vegetables/Vegetable Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
26 - - - -- Vegetable Oils
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
27 - - - -- Dressing/Condiments
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
28 - - - -- Spices, Flavors And Salts
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
31 - - - -- Coffee/Tea
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
32 - - - -- Alcoholic Beverages
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
38 - - - -- Soups
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
39 - - - -- Prepared Salad Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 A - - -- Baked Goods (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 B - - -- Cereal (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 D - - -- Veg (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 J - - -- Egg Prod (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 K - - -- Pudding/Custard (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 X - - -- Market Basket Sampling
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 Y - - -- Baby Food N.E.C.
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 06 Corn Husks (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 07 Snail Shells (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 12 Non-Edible Bird's Nest
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 D - - -- Live Animals
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/17/2015
Desc: All Dietary Supplements
Notes: Firm placed on IA due to violative inspection done at firm.
Mas Natural Salud Y Bienestar
Date Published : 06/17/2015
Calle Escuadron 201 24la Moderna , Col. Moderna, Irapuato
, Irapuato,
Guanajuato MEXICO
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
04 - - - -- Macaroni/Noodle Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
07 - - - -- Snack Food Items
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
12 - - - -- Cheese/Cheese Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
13 - - - -- Ice Cream and related Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
15 - - - -- Eggs/Egg Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
16 - - - -- Fishery/Seafood Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
17 - - - -- Meats, Meat Products and Poultry
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
18 - - - -- Vegetable Protein Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
20 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
21 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
22 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
23 - - - -- Nuts/Edible Seeds
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
24 - - - -- Vegetables/Vegetable Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
25 - - - -- Vegetables/Vegetable Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
26 - - - -- Vegetable Oils
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
27 - - - -- Dressing/Condiments
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
28 - - - -- Spices, Flavors And Salts
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
31 - - - -- Coffee/Tea
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
32 - - - -- Alcoholic Beverages
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
38 - - - -- Soups
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
39 - - - -- Prepared Salad Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 A - - -- Baked Goods (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 B - - -- Cereal (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 D - - -- Veg (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 J - - -- Egg Prod (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 K - - -- Pudding/Custard (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 X - - -- Market Basket Sampling
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 Y - - -- Baby Food N.E.C.
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 06 Corn Husks (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 07 Snail Shells (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 12 Non-Edible Bird's Nest
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 D - - -- Live Animals
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
Mas Natural Salud y Bienestar, S. de R.L. de C.V.
Date Published : 06/17/2015
Calle Emilio Carranza No. 1055 , Col. RODRIGUEZ
, Irapuato,
Guanajuato MEXICO
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
04 - - - -- Macaroni/Noodle Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
07 - - - -- Snack Food Items
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
12 - - - -- Cheese/Cheese Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
13 - - - -- Ice Cream and related Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
15 - - - -- Eggs/Egg Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
16 - - - -- Fishery/Seafood Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
17 - - - -- Meats, Meat Products and Poultry
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
18 - - - -- Vegetable Protein Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
20 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
21 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
22 - - - -- Fruit/Fruit Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
23 - - - -- Nuts/Edible Seeds
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
24 - - - -- Vegetables/Vegetable Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
25 - - - -- Vegetables/Vegetable Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
26 - - - -- Vegetable Oils
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
27 - - - -- Dressing/Condiments
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
28 - - - -- Spices, Flavors And Salts
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
31 - - - -- Coffee/Tea
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
32 - - - -- Alcoholic Beverages
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
38 - - - -- Soups
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
39 - - - -- Prepared Salad Products
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 A - - -- Baked Goods (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 B - - -- Cereal (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 D - - -- Veg (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 J - - -- Egg Prod (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 K - - -- Pudding/Custard (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 X - - -- Market Basket Sampling
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
40 Y - - -- Baby Food N.E.C.
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 06 Corn Husks (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 07 Snail Shells (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 B - - 12 Non-Edible Bird's Nest
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
52 D - - -- Live Animals
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 06/17/2015
Notes: All Dietary Supplements; Firm placed on IA due to violative inspection done
at firm
Olnatura, S. A. de C. V.
Date Published : 11/03/2015
Sur, Mnz. 40 Pb 8 , Civac
, Jiutepec,
Morelos MEXICO
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 11/03/2015
Desc: All Vit/Min/Prot/Unconv Diet (Human/Animal)
Notes: FDA inspection; conducted 4/13-14/2015; found serious violations of the Dietary Supplement cGMP.
Tonic Life S de RL
Date Published : 04/02/2020
Calle Acambaro 1008 , Col. Fracc Plan De Guanajuato, Irapuato
, Irapuato,
Guanajuato MEXICO
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 04/02/2020
Notes: All Dietary Supplements
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 04/02/2020
Notes: All Dietary Supplements
04 - - - -- Macaroni/Noodle Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 04/02/2020
Notes: All Dietary Supplements
07 - - - -- Snack Food Items
Date Published: 04/02/2020
Notes: All Dietary Supplements
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
12 - - - -- Cheese/Cheese Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
13 - - - -- Ice Cream and related Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
15 - - - -- Eggs/Egg Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
16 - - - -- Fishery/Seafood Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
17 - - - -- Meats, Meat Products and Poultry
Date Published: 04/02/2020
Notes: All Dietary Supplements
18 - - - -- Vegetable Protein Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
20 - - - -- Fruit/Fruit Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
21 - - - -- Fruit/Fruit Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
22 - - - -- Fruit/Fruit Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
23 - - - -- Nuts/Edible Seeds
Date Published: 04/02/2020
Notes: All Dietary Supplements
24 - - - -- Vegetables/Vegetable Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
25 - - - -- Vegetables/Vegetable Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
26 - - - -- Vegetable Oils
Date Published: 04/02/2020
Notes: All Dietary Supplements
27 - - - -- Dressing/Condiments
Date Published: 04/02/2020
Notes: All Dietary Supplements
28 - - - -- Spices, Flavors And Salts
Date Published: 04/02/2020
Notes: All Dietary Supplements
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 04/02/2020
Notes: All Dietary Supplements
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 04/02/2020
Notes: All Dietary Supplements
31 - - - -- Coffee/Tea
Date Published: 04/02/2020
Notes: All Dietary Supplements
32 - - - -- Alcoholic Beverages
Date Published: 04/02/2020
Notes: All Dietary Supplements
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 04/02/2020
Notes: All Dietary Supplements
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 04/02/2020
Notes: All Dietary Supplements
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 04/02/2020
Notes: All Dietary Supplements
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 04/02/2020
Notes: All Dietary Supplements
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 04/02/2020
Notes: All Dietary Supplements
38 - - - -- Soups
Date Published: 04/02/2020
Notes: All Dietary Supplements
39 - - - -- Prepared Salad Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 A - - -- Baked Goods (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 B - - -- Cereal (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 D - - -- Veg (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 J - - -- Egg Prod (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 K - - -- Pudding/Custard (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 X - - -- Market Basket Sampling
Date Published: 04/02/2020
Notes: All Dietary Supplements
40 Y - - -- Baby Food N.E.C.
Date Published: 04/02/2020
Notes: All Dietary Supplements
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 04/02/2020
42 B - - -- Milled Edible Insect Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 C - - -- Edible Insect Bars
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 D - - -- Edible Insect Bakery Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 G - - -- Edible Insect Capsules
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 I - - -- Edible Insect Jerky
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 K - - -- Edible Insect Oils
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 L - - -- Edible Insect Smoothies
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 M - - -- Edible Insect Soups
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 O - - -- Edible Insect Beverages
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 Q - - -- Edible Insect Salts and Spices
Date Published: 04/02/2020
Notes: All Dietary Supplements
42 R - - -- Edible Insect Products N.E.C.
Date Published: 04/02/2020
Notes: All Dietary Supplements
52 B - - 06 Corn Husks (Food Related)
Date Published: 04/02/2020
Notes: All Dietary Supplements
52 B - - 07 Snail Shells (Food Related)
Date Published: 04/02/2020
Notes: All Dietary Supplements
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 04/02/2020
Notes: All Dietary Supplements
52 B - - 12 Non-Edible Bird's Nest
Date Published: 04/02/2020
Notes: All Dietary Supplements
52 D - - -- Live Animals
Date Published: 04/02/2020
Notes: All Dietary Supplements
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/02/2020
Desc: All Dietary Supplements
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 04/02/2020
Notes: All Dietary Supplements
NEW ZEALAND
Xtend-Life Group Limited
Date Published : 07/03/2025
12 Mary Muller Drive, Hillsborough
, Christchurch,
Canterbury NEW ZEALAND
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/03/2025
Desc: Marine Magnesium with Potassium Capsules
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.113 (b)(2) and 21 CFR 111.70 (e) , indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/03/2025
Desc: Prostate Support Capsules
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.113 (b)(2) and 21 CFR 111.70 (e) , indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
65 C - - 03 Potassium Aspartate and Magnesium Aspartate (Nutrient/Tonic)
Date Published: 07/03/2025
Desc: Prostate Support Capsules
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.113 (b)(2) and 21 CFR 111.70 (e) , indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
65 C - - 03 Potassium Aspartate and Magnesium Aspartate (Nutrient/Tonic)
Date Published: 07/03/2025
Desc: Marine Magnesium with Potassium Capsules
Notes: FDA inspected the foreign food manufacturing facility and found serious deviations of the FDA’s Current Good Manufacturing Practices (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Based on the firm’s failure to comply with 21 CFR 111, it appears that all of the dietary supplement products that the firm manufactures are adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not comply with the cGMP regulations for dietary supplements. Specific violations of 21 CFR 111.113 (b)(2) and 21 CFR 111.70 (e) , indicate a systemic GMP concern for the firm’s manufacturing of dietary supplement products.
SPAIN
laboratorios tegor
Date Published : 07/16/2018
Poligono Industrial Ugaldeguren 1
, Zamudio,
Vizcaya SPAIN
54 Y C A -- Vit/Min/Prot/Unconv Diet Spec N.E.C., Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 07/16/2018
Desc: Omega Aging
54 Y C A -- Vit/Min/Prot/Unconv Diet Spec N.E.C., Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 07/16/2018
Desc: LaviGor brand Lavimeno
54 Y C A -- Vit/Min/Prot/Unconv Diet Spec N.E.C., Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 07/16/2018
Desc: LaviGor brand Laviprobiotic Forte
54 Y C A -- Vit/Min/Prot/Unconv Diet Spec N.E.C., Hum Fd Dietary Suppl Multi Ingr, Prompt Release Tablets
Date Published: 07/16/2018
Desc: LaviGor brand Colagen Supra Plus
UNITED KINGDOM
Parkacre Limited
Date Published : 02/28/2024
Hangar 2 , Industrial Estate; Learoyd Road; Caenby Corner Estate; Lincoln
, Gainsborough,
Lincolnshire UNITED KINGDOM
02 - - - -- Whole Grains/Milled Grain Products/Starches
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
03 - - - -- Bakery Products/Dough/Mixes/Icings
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
04 - - - -- Macaroni/Noodle Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
05 - - - -- Cereal Preparations/Breakfast Foods
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
07 - - - -- Snack Food Items
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
09 - - - -- Milk/Butter/Dried Milk Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
12 - - - -- Cheese/Cheese Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
13 - - - -- Ice Cream and related Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
14 - - - -- Filled Milk/Imitation Milk Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
15 - - - -- Eggs/Egg Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
16 - - - -- Fishery/Seafood Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
17 - - - -- Meats, Meat Products and Poultry
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
18 - - - -- Vegetable Protein Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
20 - - - -- Fruit/Fruit Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
21 - - - -- Fruit/Fruit Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
22 - - - -- Fruit/Fruit Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
23 - - - -- Nuts/Edible Seeds
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
24 - - - -- Vegetables/Vegetable Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
25 - - - -- Vegetables/Vegetable Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
26 - - - -- Vegetable Oils
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
27 - - - -- Dressing/Condiments
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
28 - - - -- Spices, Flavors And Salts
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
29 - - - -- Drinks, Soft Drinks, and Waters
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
30 - - - -- Beverage Bases/Concentrates/Nectars
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
31 - - - -- Coffee/Tea
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
32 - - - -- Alcoholic Beverages
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
33 - - - -- Candy W/O Chocolate/Candy Specialties/Chewing Gums
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
34 - - - -- Chocolate/Cocoa Products/Cocoa beans
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
35 - - - -- Gelatin/Rennet/Pudding Mixes/Pie Fillings
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
36 - - - -- Food Sweeteners/Nutritive syrups/honey/molasses
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
37 - - - -- Multiple food dinners/Gravies/Sauces/Specialties
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
38 - - - -- Soups
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
39 - - - -- Prepared Salad Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 A - - -- Baked Goods (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 B - - -- Cereal (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 D - - -- Veg (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 J - - -- Egg Prod (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 K - - -- Pudding/Custard (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 L - - -- Soups/Soup Mix (Baby)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 X - - -- Market Basket Sampling
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
40 Y - - -- Baby Food N.E.C.
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 A - - -- Whole Edible Insects (adults and immature stages)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 B - - -- Milled Edible Insect Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 C - - -- Edible Insect Bars
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 D - - -- Edible Insect Bakery Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 E - - -- Edible Insect Candy With Chocolate
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 F - - -- Edible Insect Candy Without Chocolate
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 G - - -- Edible Insect Capsules
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 H - - -- Edible Insect Granola or Trail Mix
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 I - - -- Edible Insect Jerky
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 J - - -- Edible Insect Ice Cream and Related Products
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 K - - -- Edible Insect Oils
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 L - - -- Edible Insect Smoothies
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 M - - -- Edible Insect Soups
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 N - - -- Edible Insect Spreads And Pastes
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 O - - -- Edible Insect Beverages
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 P - - -- Edible Insect Protein: Simulated Meats and Tofu
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 Q - - -- Edible Insect Salts and Spices
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
42 R - - -- Edible Insect Products N.E.C.
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
52 B - - 06 Corn Husks (Food Related)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
52 B - - 07 Snail Shells (Food Related)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
52 B - - 12 Non-Edible Bird's Nest
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
52 D - - -- Live Animals
Date Published: 02/28/2024
Notes: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/28/2024
Desc: All Dietary Supplement Products
54 - - - -- Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)
Date Published: 02/28/2024
Notes: All Dietary Supplement Products