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: 08/30/2017
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT
PRODUCTS FROM FIRMS WHICH HAVE NOT MET DIETARY SUPPLEMENT GMPS

Reason for Alert:

NOTE: The revision to this Import Alert dated 03/18/2016 is to update the CFSAN
contact information. Changes are noted and bracketed with three 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 34942].

The final rule created Title 21, part 111 (21 CFR Part 111), which establishes 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. 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 affected products if inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement products will be removed from detention without physical examination.

Guidance:

Districts may detain, without physical sampling and analysis, all dietary supplement products from the foreign processors (manufacturers) as noted in the Red List of this import alert.

DWPE will be indicated when CFSAN determines that inspectional findings demonstrate the manufacture of dietary supplement products is not operating in conformity with current good manufacturing practices (GMP's).

Foreign processors listed on the Red List of this import alert may request removal from that list by submitting documentation demonstrating that the firm is in compliance with the CGMP regulation (21 CFR, Part 111). The documentation may include reports from a third-party (e.g., a government inspection authority) demonstrating that an inspection of the processor was conducted and that dietary supplement products are manufactured in accordance with CGMPs.

The above documentation should be submitted to CFSAN's Office of Compliance, Division of Enforcement, at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance
Division of Enforcement
***Labeling and Dietary Supplement Compliance Branch,
(HFS-608)***

5100 Paint Branch Parkway
College Park, MD 20740
***Questions should be addressed to CFSAN/Division of Enforcement
(HFS-608) at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov.***

Product Description:

Dietary Supplements, Bulk or Finished

PROBLEM: Failure to meet Dietary Supplement GMPs

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the dietary supplement product 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: SUPPLGMP

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


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:Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement Tablets

54 E - - -- Herbal and Botanical
Date Published: 04/24/2017

Desc:Huang Lian Su Herbal Supplement Tablets

54 F - - -- Herbal & Botanicals(other than teas)
Date Published: 04/24/2017

Desc:Huang Lian Su Herbal 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 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: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

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

Life Rising (Tianjin) Natural Product R&D Center LTD
Date Published : 12/13/2016
# 12 Luyuandao , Wuqing , Tianjin, Tianjin CHINA
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

04 - - - -- Macaroni/Noodle Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

07 - - - -- Snack Food Item
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 Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

12 - - - -- Cheese/Cheese Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

13 - - - -- Ice Cream Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

15 - - - -- Egg/Egg Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

16 - - - -- Fishery/Seafood Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

17 - - - -- Meat, 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 Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

20 - - - -- Fruit/Fruit Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

21 - - - -- Fruit/Fruit Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

22 - - - -- Fruit/Fruit Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

23 - - - -- Nuts/Edible Seed
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/Condiment
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 - - - -- Soft Drink/Water
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

30 - - - -- Beverage Bases/Conc/Nectar
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 Beverage
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

34 - - - -- Choc/Cocoa Prod
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

38 - - - -- Soup
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

39 - - - -- Prep Salad Prod
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 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 12/13/2016

Notes:All Dietary Supplements;CFSAN recommended placing firm on IA due to violative foreign inspection

Tianjin Medicines & Health Products Imp & Exp Corp
Date Published : 01/13/2017
6 Tangshan Road , Tianjin, Tianjin CHINA
02 - - - -- Whole Grain/Milled Grain Prod/Starch
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 FDAs 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 Prod/Dough/Mix/Icing
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 FDAs 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 Prod
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 FDAs 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 Prep/Breakfast Food
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 FDAs 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 Item
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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/Imit Milk Prod
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 FDAs 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 - - - -- Egg/Egg Prod
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 FDAs 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 Prod
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 FDAs 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 - - - -- Meat, 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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Seed
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 FDAs 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 FDAs 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 FDAs 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 FDAs 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/Condiment
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 FDAs 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 FDAs 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 - - - -- Soft Drink/Water
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 FDAs 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/Conc/Nectar
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 FDAs 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 FDAs 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 Beverage
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 FDAs 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 Choc/Special/Chew Gum
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 FDAs 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 - - - -- Choc/Cocoa Prod
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 FDAs 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 Mix/Pie Filling
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 FDAs 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)
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 FDAs 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 - - - -- Mult Food Dinner/Grav/Sauce/Special
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 FDAs 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 - - - -- Soup
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 FDAs 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 - - - -- Prep Salad Prod
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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 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 FDAs 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 FDAs 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 FDAs 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 Grain/Milled Grain Prod/Starch
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 FDAs 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 Prod/Dough/Mix/Icing
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 FDAs 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 Prod
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 FDAs 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 Prep/Breakfast Food
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 FDAs 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 Item
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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/Imit Milk Prod
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 FDAs 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 - - - -- Egg/Egg Prod
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 FDAs 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 Prod
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 FDAs 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 - - - -- Meat, 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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Prod
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 FDAs 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 Seed
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 FDAs 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 FDAs 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 FDAs 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 FDAs 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/Condiment
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 FDAs 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 FDAs 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 - - - -- Soft Drink/Water
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 FDAs 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/Conc/Nectar
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 FDAs 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 FDAs 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 Beverage
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 FDAs 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 Choc/Special/Chew Gum
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 FDAs 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 - - - -- Choc/Cocoa Prod
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 FDAs 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 Mix/Pie Filling
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 FDAs 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)
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 FDAs 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 - - - -- Mult Food Dinner/Grav/Sauce/Special
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 FDAs 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 - - - -- Soup
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 FDAs 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 - - - -- Prep Salad Prod
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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 FDAs 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 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 FDAs 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 FDAs 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 FDAs 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).


DOMINICAN REPUBLIC


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
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

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: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: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 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: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: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


INDIA


Patanjali Ayurved
Date Published : 04/06/2015
D - 38 , Haridwar, Uttarakhand INDIA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 04/06/2015

Notes:Product Description /Product Code(s): All dietary supplements Notes: FDA inspection found serious deviations of the cGMP.


ITALY


Forza Vitale Italia S.r.l.
Date Published : 06/06/2017
Via Castel del Monte 194 / C , Corato, Bari ITALY
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 06/06/2017

Desc:All Dietary Supplements
Notes:FDA inspection found serious deviations from Dietary Supplement cGMP.


JAPAN


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 FDAs 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 firms 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.


MALAYSIA


Phyto Science
Date Published : 08/30/2017
9 PT Jalan 9/8 , Bandar Baru Bangi, Selangor MALAYSIA
54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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, 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:Forte Concentrated 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: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: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: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.)

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.)

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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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.

Healthy People Labs S de RL de CV
Date Published : 08/19/2015
Prolongacion Avenida Alvaro Obregon 145 , Colonia Los Hoyos , Irapuato, MX-GUA MEXICO
54 E - - 99 Herbals & Botanical Teas, N.E.C.
Date Published: 08/19/2015

Desc:Rena Extreme

54 E - - 99 Herbals & Botanical Teas, 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: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

Herbolaris Internacional
Date Published : 12/17/2014
Los Robles 122 , Zapopan, Jal 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 , Colonia Serrano , Irapuato, GTO MEXICO
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

04 - - - -- Macaroni/Noodle Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

07 - - - -- Snack Food Item
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 Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

12 - - - -- Cheese/Cheese Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

13 - - - -- Ice Cream Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

15 - - - -- Egg/Egg Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

16 - - - -- Fishery/Seafood Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

17 - - - -- Meat, 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 Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

20 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

21 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

22 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

23 - - - -- Nuts/Edible Seed
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/Condiment
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 - - - -- Soft Drink/Water
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

30 - - - -- Beverage Bases/Conc/Nectar
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 Beverage
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

34 - - - -- Choc/Cocoa Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

38 - - - -- Soup
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

39 - - - -- Prep Salad Prod
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 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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
Escuadron 201 24la Moderna , Irapuatoguanajuato, MEXICO
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

04 - - - -- Macaroni/Noodle Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

07 - - - -- Snack Food Item
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 Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

12 - - - -- Cheese/Cheese Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

13 - - - -- Ice Cream Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

15 - - - -- Egg/Egg Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

16 - - - -- Fishery/Seafood Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

17 - - - -- Meat, 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 Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

20 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

21 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

22 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

23 - - - -- Nuts/Edible Seed
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/Condiment
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 - - - -- Soft Drink/Water
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

30 - - - -- Beverage Bases/Conc/Nectar
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 Beverage
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

34 - - - -- Choc/Cocoa Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

38 - - - -- Soup
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

39 - - - -- Prep Salad Prod
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 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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
Emilio Carranza No. 1055 , Colonia Rodriguez , Irapuato, Guanajuato MEXICO
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

04 - - - -- Macaroni/Noodle Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

07 - - - -- Snack Food Item
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 Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

12 - - - -- Cheese/Cheese Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

13 - - - -- Ice Cream Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

15 - - - -- Egg/Egg Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

16 - - - -- Fishery/Seafood Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

17 - - - -- Meat, 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 Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

20 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

21 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

22 - - - -- Fruit/Fruit Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

23 - - - -- Nuts/Edible Seed
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/Condiment
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 - - - -- Soft Drink/Water
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

30 - - - -- Beverage Bases/Conc/Nectar
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 Beverage
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

34 - - - -- Choc/Cocoa Prod
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

38 - - - -- Soup
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

39 - - - -- Prep Salad Prod
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 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 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
Date Published: 06/17/2015

Notes:All Dietary Supplements; Firm placed on IA due to violative inspection done at firm

Natural Health II SA de CV
Date Published : 07/16/2015
Calle Centauro Del Norte 1065 , Colonia las Eras , Irapuato, Guanajuato MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/16/2015

Desc:Rednatura Belim

Natural Health II SA de CV.
Date Published : 07/16/2015
Avenida De Los Insurgentes 3024 , Colonia La Ganadera , Irapuato, Guanajuato MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/16/2015

Desc:Rednatura Oxialoe

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 07/16/2015

Desc:Rednatura Repibon

Olnatura, S. A. de C. V.
Date Published : 11/03/2015
Sur, Mnz. 40 Pb 8 , Civac , Jiutepec, Morelos MEXICO
54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/03/2015

Desc:Biogaxtric
Notes:FDA inspection; conducted 4/13-14/2015; found serious violations of the Dietary Supplement cGMP.

54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
Date Published: 11/03/2015

Desc:Dietgenix Shake
Notes:FDA inspection; conducted 4/13-14/2015; found serious violations of the Dietary Supplement cGMP.

54 - - - -- Vit/Min/Prot/Unconv Diet(Human/Animal)
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.


NORWAY


Medpalett AS
Date Published : 01/13/2017
Hanaveien 4-6 , Sandnes, None of the above NORWAY
54 F - - 98 Bilberry (Herbal & Botanicals, not Teas)
Date Published: 01/13/2017

Desc:Medox
Notes:The FDA inspected the above referenced foreign dietary supplement distributor on June 15-17; 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).