Import Alert 99-35

(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 # 99-35
Published Date: 10/13/2017
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF FRESH PRODUCE THAT

APPEARS TO HAVE BEEN PREPARED, PACKED OR HELD UNDER INSANITARY

CONDITIONS

Reason for Alert:

This import alert represents the Agency's current guidance to the Food and Drug Administration (FDA) field personnel regarding the manufacturer(s) and/or product(s) at issue. It does not create or confer any rights for or any person, and does not operate to bind FDA or the public.



Produce is vulnerable to contamination with pathogenic microorganisms if exposed to insanitary conditions during growing, harvesting, packing, holding, or manufacturing, processing, or transportation. Multiple foodborne illness outbreaks have been linked to produce items that were likely contaminated as a result of insanitary conditions during growing, harvesting, packing, holding, manufacturing, processing, or transportation. Produce is of special concern because in many instances it is consumed without further treatment to adequately destroy or remove pathogenic microorganisms.



FDA may document insanitary conditions during an inspection of an establishment that grows, harvests, packs, holds, manufactures, processes, or transports produce. FDA may also use analytical evidence or epidemiological and traceback evidence to establish that a produce item was manufactured, processed, prepared, packed, or held under insanitary conditions.

Guidance:

Districts may detain, without physical examination, produce items from manufacturers, shippers, farms, packers and/or other entities (firms) identified on the Red List of this import alert.



Examples of evidence FDA may use to place a firm on the Red List include:



1. Inspectional evidence.



2. Epidemiological evidence and traceback evidence. This should include evidence implicating the particular produce item as a vehicle in a foodborne illness outbreak (including positive test results), traceback evidence demonstrating that the firm grows, harvests, packs, holds, manufactures, processes, or transports the implicated vehicle, and expert opinion that the outbreak was likely a result of insanitary conditions at the foreign firm (e.g., contamination likely resulted from insanitary conditions due to the typical modes of transmission of the pathogen implicated in the outbreak) or was related to a resident pathogen or systemic contamination at the foreign firm, or both.



3. Analytical evidence. This should include evidence of a resident organism at the foreign firm and/or systemic contamination at the foreign firm, such as an expert opinion that the analytical evidence indicates insanitary conditions at the foreign firm or indicates a resident pathogen or systemic contamination at the foreign firm, or both. Examples include:



* A pathogen that matches an outbreak strain is isolated from an imported produce item;



* Microbial pathogens that are indistinguishable by one or more genetic tests are isolated from two or more lots of imported produce originating from the same foreign firm.



INFORMATION FOR FIRMS REQUESTING REMOVAL FROM THE RED LIST:



In order to be removed from the red list, the firm should submit documentation to FDA demonstrating that the firm has made all relevant corrections to overcome the appearance of adulteration, so that the agency will have confidence that future entries will be in compliance with the Act. Examples of such documentation may include:



1. Documentation to show that inspectional observations or violations identified by FDA have been corrected. Firms whose produce items appear to be adulterated based on inspectional evidence should submit detailed descriptions of the specific steps taken to correct the violations along with documentation such as (as applicable) written plans, field records, packinghouse or facility records, training records, and photographs.



2. Root cause analysis to identify potential sources and routes of contamination. Firms whose produce items appear to be adulterated based on analytical or epidemiological and traceback evidence should include a detailed root cause analysis to evaluate all aspects of their operations in order to identify potential sources and routes of contamination. The firm should also provide documentation to demonstrate that corrective actions to adequately control the sources and routes of contamination identified in the root cause analysis have been implemented.



FDA recommends that the firm's submission be organized according to the following areas, as appropriate to the firm's practices, processes, and procedures:

- Water adequacy for irrigation, agricultural sprays, cooling, and other uses;

- Soil amendment and biosolids;

- Animal management;

- Worker health and hygiene;

- Sanitary facilities, disposal of sewage and silage;

- Equipment cleaning and sanitation;

- Farm or facility sanitation;

- Transportation; and

- Programs to monitor produce safety practices, processes and procedures and to take corrective actions when measures fail or are not fully implemented.



The firm may wish to refer to FDA's Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables, or similar guidance, to assist them in their root cause analysis and corrective action. Additional guidance for produce, including commodity specific guidance, may be found the FDA website at www.FDA.gov.



All requests for removal from detention without physical examination may be sent via email to: Importalerts2@fda.hhs.gov



Or mailed to:



Food and Drug Administration

Division of Import Operations

12420 Parklawn Drive, ELEM-3109

Rockville, MD 20857



Requests for removal from detention without physical examination will be referred by DIOP to CFSAN (HFS-605) for evaluation.



FDA may also choose to evaluate the firm's corrective actions during an inspection of the firm.



NOTE: Since the article is subject to Refusal of Admission per Section 801(a)(1) of the Act, FDA considers submission of analytical results to be insufficient to overcome the appearance of the product having been prepared, packed, or held under insanitary conditions. In addition, the appearance of a violation per Section 801(a)(1) of the Act precludes reconditioning under Section 801(b) of the Act.



CONTACT INFORMATION:



For questions on policy or produce items for examination and sampling, contact CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch at (240) 402-1750



For questions or issues concerning import operations, contact DIO, Import Operations and Maintenance Branch at (301) 796-0356.

Product Description:

PRODUCT: Produce (fruit or vegetable)



PRODUCT

CODE: See Red List



PROBLEM: INSANITARY CONDITIONS

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4) of the Act]."

OASIS Charge Code: MFR INJ



and



"The article is subject to refusal of admission pursuant to Section 801(a)(1) of the Act in that it appears to have been manufactured, processed, or packed under insanitary conditions."

OASIS Charge Code: MFR INSAN

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


CHINA


Taian Runko Industry International Trade Co. Ltd.
Date Published : 05/02/2017
Room No. 0111-B Shengdi Gongyu , No. 62 Great Wall Rd. , Taian, Shandong CHINA
20 A - - 13 Raspberries, Red (Berry)
Date Published: 05/02/2017

Desc:Individually Quick Frozen (IQF) Red Raspberries
Notes:Problem: Norovirus GII


EGYPT


The Int'l. Company For Agricultural Production & Processing
Date Published : 10/19/2016
Industrial Zone A2 (Lot W) , 10th Of Ramadan City, EG-SHR EGYPT
20 A - - 14 Strawberries (Berry)
Date Published: 10/19/2016

Desc:Frozen Strawberries
Notes:                                                                                                                                                                                                                                                                                                                                                                       Problem(s): Hepatitis A (1b)


MEXICO


CULTIVO Y EMPAQUES AGRICOLAS, S.A. DE C.V.
Date Published : 05/28/2015
Boulevard los Laureles S/N , Cuapiaxtla de Madero, Puebla MEXICO
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 05/28/2015

Notes:All food products

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 05/28/2015

Notes:All food products

04 - - - -- Macaroni/Noodle Prod
Date Published: 05/28/2015

Notes:All food products

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 05/28/2015

Notes:All food products

07 - - - -- Snack Food Item
Date Published: 05/28/2015

Notes:All food products

09 - - - -- Milk/Butter/Dried Milk Prod
Date Published: 05/28/2015

Notes:All food products

12 - - - -- Cheese/Cheese Prod
Date Published: 05/28/2015

Notes:All food products

13 - - - -- Ice Cream Prod
Date Published: 05/28/2015

Notes:All food products

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 05/28/2015

Notes:All food products

15 - - - -- Egg/Egg Prod
Date Published: 05/28/2015

Notes:All food products

16 - - - -- Fishery/Seafood Prod
Date Published: 05/28/2015

Notes:All food products

17 - - - -- Meat, Meat Products and Poultry
Date Published: 05/28/2015

Notes:All food products

18 - - - -- Vegetable Protein Prod
Date Published: 05/28/2015

Notes:All food products

20 - - - -- Fruit/Fruit Prod
Date Published: 05/28/2015

Notes:All food products

21 - - - -- Fruit/Fruit Prod
Date Published: 05/28/2015

Notes:All food products

22 - - - -- Fruit/Fruit Prod
Date Published: 05/28/2015

Notes:All food products

23 - - - -- Nuts/Edible Seed
Date Published: 05/28/2015

Notes:All food products

24 - - - -- Vegetables/Vegetable Products
Date Published: 05/28/2015

Notes:All food products

25 - - - -- Vegetables/Vegetable Products
Date Published: 05/28/2015

Notes:All food products

26 - - - -- Vegetable Oils
Date Published: 05/28/2015

Notes:All food products

27 - - - -- Dressing/Condiment
Date Published: 05/28/2015

Notes:All food products

28 - - - -- Spices, Flavors And Salts
Date Published: 05/28/2015

Notes:All food products

29 - - - -- Soft Drink/Water
Date Published: 05/28/2015

Notes:All food products

30 - - - -- Beverage Bases/Conc/Nectar
Date Published: 05/28/2015

Notes:All food products

31 - - - -- Coffee/Tea
Date Published: 05/28/2015

Notes:All food products

32 - - - -- Alcoholic Beverage
Date Published: 05/28/2015

Notes:All food products

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 05/28/2015

Notes:All food products

34 - - - -- Choc/Cocoa Prod
Date Published: 05/28/2015

Notes:All food products

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 05/28/2015

Notes:All food products

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 05/28/2015

Notes:All food products

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 05/28/2015

Notes:All food products

38 - - - -- Soup
Date Published: 05/28/2015

Notes:All food products

39 - - - -- Prep Salad Prod
Date Published: 05/28/2015

Notes:All food products

40 A - - -- Baked Goods (Baby)
Date Published: 05/28/2015

Notes:All food products

40 B - - -- Cereal (Baby)
Date Published: 05/28/2015

Notes:All food products

40 D - - -- Veg (Baby)
Date Published: 05/28/2015

Notes:All food products

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 05/28/2015

Notes:All food products

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 05/28/2015

Notes:All food products

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 05/28/2015

Notes:All food products

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 05/28/2015

Notes:All food products

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 05/28/2015

Notes:All food products

40 J - - -- Egg Prod (Baby)
Date Published: 05/28/2015

Notes:All food products

40 K - - -- Pudding/Custard (Baby)
Date Published: 05/28/2015

Notes:All food products

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 05/28/2015

Notes:All food products

40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 05/28/2015

Notes:All food products

40 X - - -- Market Basket Sampling
Date Published: 05/28/2015

Notes:All food products

40 Y - - -- Baby Food N.E.C.
Date Published: 05/28/2015

Notes:All food products

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 05/28/2015

Notes:All food products

52 B - - 06 Corn Husks (Food Related)
Date Published: 05/28/2015

Notes:All food products

52 B - - 07 Snail Shells (Food Related)
Date Published: 05/28/2015

Notes:All food products

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 05/28/2015

Notes:All food products

52 B - - 12 Bird's Nest
Date Published: 05/28/2015

Notes:All food products

52 D - - -- Live Animals
Date Published: 05/28/2015

Notes:All food products

Caraveo Produce S.A. de C.V.
Date Published : 10/04/2017
Calle Miguel Bracamontes 15 , Col. CENTRO , Tecoman, Colima MEXICO
21 S - - 06 Papaya (Papaw) (Subtropical and Tropical Fruit)
Date Published: 10/04/2017

Desc:Papaya
Problems: SALMONELLA;

Carica de Campeche SPR de RL
Date Published : 08/07/2017
Calle 5 s/n , Col. Jacinto Canek a 50 Mts , Tenabo, Camp MEXICO
21 S - - 06 Papaya (Papaw) (Subtropical and Tropical Fruit)
Date Published: 08/07/2017

Desc:Fresh Papaya
Problems: SALMONELLA;

EL ZAPOTANITO
Date Published : 10/04/2017
Km 19.8 Carr. Fed. Melaque-Pto Vallarta , La Manzanilla , LA Huerta, Jal MEXICO
21 S - - 06 Papaya (Papaw) (Subtropical and Tropical Fruit)
Date Published: 10/04/2017

Desc:Papayas
Problems: SALMONELLA;

ELIAS GERARDO GONZALEZ VALDEZ
Date Published : 11/10/2016
Av Ciudad De Los Angeles 42 , San Nicolas De Los Garza, NL MEXICO
24 F - - 08 Pepper, Hot, N.E.C. (Fruit Used as Vegetable)
Date Published: 11/10/2016

Desc:Anaheim Peppers

24 F - - 08 Pepper, Hot, N.E.C. (Fruit Used as Vegetable)
Date Published: 11/10/2016

Desc:Hot Peppers

24 F - - 12 Jalapeno Pepper, Hot (Fruit Used as Vegetable)
Date Published: 11/10/2016

Desc:Jalapeno Peppers

24 F - - 12 Jalapeno Pepper, Hot (Fruit Used as Vegetable)
Date Published: 11/10/2016

Desc:Hot Peppers

24 F - - 13 Serrano Pepper, Hot (Fruit Used as Vegetable)
Date Published: 11/10/2016

Desc:Serrano Peppers

24 F - - 13 Serrano Pepper, Hot (Fruit Used as Vegetable)
Date Published: 11/10/2016

Desc:Hot Peppers

Evodio Gonzalez Chavez
Date Published : 05/22/2015
Carretera Federal Empalme Perote Km 3.40 , Pueblo Miguel Negrete , Cuapiaxtla de Madero, Puebla MEXICO
02 - - - -- Whole Grain/Milled Grain Prod/Starch
Date Published: 05/22/2015

03 - - - -- Bakery Prod/Dough/Mix/Icing
Date Published: 05/22/2015

04 - - - -- Macaroni/Noodle Prod
Date Published: 05/22/2015

05 - - - -- Cereal Prep/Breakfast Food
Date Published: 05/22/2015

07 - - - -- Snack Food Item
Date Published: 05/22/2015

09 - - - -- Milk/Butter/Dried Milk Prod
Date Published: 05/22/2015

12 - - - -- Cheese/Cheese Prod
Date Published: 05/22/2015

13 - - - -- Ice Cream Prod
Date Published: 05/22/2015

14 - - - -- Filled Milk/Imit Milk Prod
Date Published: 05/22/2015

15 - - - -- Egg/Egg Prod
Date Published: 05/22/2015

16 - - - -- Fishery/Seafood Prod
Date Published: 05/22/2015

17 - - - -- Meat, Meat Products and Poultry
Date Published: 05/22/2015

18 - - - -- Vegetable Protein Prod
Date Published: 05/22/2015

20 - - - -- Fruit/Fruit Prod
Date Published: 05/22/2015

21 - - - -- Fruit/Fruit Prod
Date Published: 05/22/2015

22 - - - -- Fruit/Fruit Prod
Date Published: 05/22/2015

23 - - - -- Nuts/Edible Seed
Date Published: 05/22/2015

24 - - - -- Vegetables/Vegetable Products
Date Published: 05/22/2015

25 - - - -- Vegetables/Vegetable Products
Date Published: 05/22/2015

26 - - - -- Vegetable Oils
Date Published: 05/22/2015

27 - - - -- Dressing/Condiment
Date Published: 05/22/2015

28 - - - -- Spices, Flavors And Salts
Date Published: 05/22/2015

29 - - - -- Soft Drink/Water
Date Published: 05/22/2015

30 - - - -- Beverage Bases/Conc/Nectar
Date Published: 05/22/2015

31 - - - -- Coffee/Tea
Date Published: 05/22/2015

32 - - - -- Alcoholic Beverage
Date Published: 05/22/2015

33 - - - -- Candy W/O Choc/Special/Chew Gum
Date Published: 05/22/2015

34 - - - -- Choc/Cocoa Prod
Date Published: 05/22/2015

35 - - - -- Gelatin/Rennet/Pudding Mix/Pie Filling
Date Published: 05/22/2015

36 - - - -- Food Sweeteners (Nutritive)
Date Published: 05/22/2015

37 - - - -- Mult Food Dinner/Grav/Sauce/Special
Date Published: 05/22/2015

38 - - - -- Soup
Date Published: 05/22/2015

39 - - - -- Prep Salad Prod
Date Published: 05/22/2015

40 A - - -- Baked Goods (Baby)
Date Published: 05/22/2015

40 B - - -- Cereal (Baby)
Date Published: 05/22/2015

40 D - - -- Veg (Baby)
Date Published: 05/22/2015

40 E - - -- Fruit/Juice/Drink (Baby)
Date Published: 05/22/2015

40 F - - -- Meat Prod/Comb Meat Dinner (Baby)
Date Published: 05/22/2015

40 G - - -- Poultry Prod/Comb Poultry Dinner (Baby)
Date Published: 05/22/2015

40 H - - -- High Meat Dinner/Cheese Food (Baby)
Date Published: 05/22/2015

40 I - - -- Fish-Seafood Prod (Baby)
Date Published: 05/22/2015

40 J - - -- Egg Prod (Baby)
Date Published: 05/22/2015

40 K - - -- Pudding/Custard (Baby)
Date Published: 05/22/2015

40 L - - -- Soups/Soup Mix (Baby)
Date Published: 05/22/2015

40 Q - - -- Pasta and Noodle Combination Dinners Without Meat
Date Published: 05/22/2015

40 X - - -- Market Basket Sampling
Date Published: 05/22/2015

40 Y - - -- Baby Food N.E.C.
Date Published: 05/22/2015

41 - - - -- Dietary Conv Food/Meal Replacements
Date Published: 05/22/2015

52 B - - 06 Corn Husks (Food Related)
Date Published: 05/22/2015

52 B - - 07 Snail Shells (Food Related)
Date Published: 05/22/2015

52 B - - 08 Sausage Casings, Artificial (Food Related)
Date Published: 05/22/2015

52 B - - 12 Bird's Nest
Date Published: 05/22/2015

52 D - - -- Live Animals
Date Published: 05/22/2015

Productores Y Exportadores De Carica Papaya De Tecoman Colim
Date Published : 10/13/2017
Calle 5 de Mayo # 571 , Col. TEPEYAC , Tecoman, Colima MEXICO
21 S - - 06 Papaya (Papaw) (Subtropical and Tropical Fruit)
Date Published: 10/13/2017

Desc:Papayas
Problems: SALMONELLA;

Rancho Don Juanito S. de R.L. de C. V.
Date Published : 09/23/2015
Carretera Transpeninsular Km 171.9 , Col. VICENTE GUERRERO , Ensenada, Baja California MEXICO
24 F - - 20 Cucumbers (Fruit Used as Vegetable)
Date Published: 09/23/2015

Desc:Cucumbers