Import Alert 99-46

(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 # 99-46
Published Date: 05/31/2022
Type: DWPE

Import Alert Name:

Detention Without Physical Examination of Imported Human Foods Due to Filth

Reason for Alert:

The FDA has found various food products that appear to be adulterated because they contain filth (including but not limited to insect, rodent, other animal filth, and/or mold).

This alert covers specific firms/products. Countrywide Detention Without Physical Examination (DWPE) recommendations due to filth are covered in other applicable import alerts (IA).

Guidance:

Divisions may detain, without physical examination, the indicated products from the firms identified on the Red List of this Import Alert.

Per Chapter 9 of the Regulatory Procedures Manual (RPM), specific product(s) from an individual firm may be added to the Red List of this alert for filth violations when:

a. There have been at least three (3) detentions in a recent six-month period or less; and
b. These detentions represent at least 25% of the total shipments of that product examined in the applicable time period as known to the recommending district or unit.

All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the appropriate Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement Branch, based on the commodity for evaluation.

Release of Articles Subject to Detention without Physical Examination under this Import Alert:

In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not contain filth. Such evidence may include private laboratory analysis of samples.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. ***Resources for private laboratory testing are available at https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing.***"

Removal from Detention without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. Per Chapter 9 of the RPM, a minimum of five (5) consecutive non-violative commercial shipments should be offered for import before the Agency may consider that the appearance of the violation has been removed. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

If a firm/product is subject to DWPE on this Import Alert and is also subject to DWPE for the same underlying violation on another filth-related Import Alert, then a request can be made to DIO that the firm or product be removed from DWPE on both Import Alerts based on the same information.

For further guidance on removal from DWPE, refer to FDA's RPM, Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

Questions or issues involving import operations should be addressed to Division of Import Operations (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

Questions or issues on human food policy or sample collection recommendations should be addressed to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov

                                                                                                                                                                       

Product Description:

Food/Food Products

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or be otherwise unfit for food. [Adulteration, Section 402(a)(3)]

OASIS charge code - FILTHY

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


ARGENTINA


Digta, S.A.
Date Published : 05/18/2022
Unknown , Buenos Aries, ARGENTINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: Fresh Garlic
Notes: Decomposition; mold; insect filth. DWPE Date; 07/01/1994

Digta, S.A.
Date Published : 05/18/2022
Unknown , Mendoza, ARGENTINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: Fresh Garlic
Notes: Decomposition; mold; insect filth. DWPE Date; 07/01/1994

Digta, S.A.
Date Published : 05/18/2022
Unknown , Santa Fe, ARGENTINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: Fresh Garlic
Notes: Decomposition; mold; insect filth. DWPE Date; 07/01/1994


CANADA


Pan Pacific Specialties Ltd
Date Published : 05/18/2022
1200 Raymur Ave , Vancouver, BC CANADA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: Peeled garlic in 5 lb jar
Notes: Decomposition. DWPE Date; 07/01/1994

Sun Pacific Food Processor
Date Published : 05/18/2022
1200 Raymur Avenue , Vancouver, BC CANADA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: Peeled garlic in 5 lb jar
Notes: Decomposition. DWPE Date; 07/01/1994


CHINA


Central China International Economic And Trading Corp
Date Published : 05/18/2022
22 Huangle Rd , Zhengzhou, CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: White garlic bulbs
Notes: Decomposition; mold; insect damage. DWPE Date; 07/01/1994

China National Medicine & Health Products Import & Export Co
Date Published : 05/18/2022
Unknown , Qingdao, Shadong CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: White garlic bulbs
Notes: Decomposition; mold; insect damage. DWPE Date; 07/01/1994

Henan Cereals Oils & Foodstuffs
Date Published : 05/18/2022
14 Jing Seventh Road , Zhengzhou, Henan CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: White garlic bulbs
Notes: Decomposition; mold; insect damage. DWPE Date; 07/01/1994

SHANDONG MEDICINES & HEALTH PRODUCTS IMP & EXP CO.
Date Published : 05/18/2022
18 Baodinglu , Shinan , Qingdao, Shandong CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: White garlic bulbs
Notes: Decomposition; mold; insect damage. DWPE Date; 07/01/1994

Weifang Import & Export Corporation
Date Published : 05/18/2022
20 Qingnan Road , Weifang, CHINA
25 J - - 21 Garlic Bulb (Root & Tuber Vegetable)
Date Published: 05/18/2022

Desc: White garlic bulbs
Notes: Decomposition; mold. DWPE Date; 07/01/1994


GREECE


Agricultural Products S.A.
Date Published : 03/08/2022
Unknown , Skidra, GREECE
21 G - E 13 Peach (Pit Fruit), Commercially Sterile
Date Published: 03/08/2022

Desc: Peaches; canned
Notes: 4/25/2001

Union Of Agricultural
Date Published : 03/08/2022
9 Papadopoulou Str , Giannitsa, GREECE
21 G - E 13 Peach (Pit Fruit), Commercially Sterile
Date Published: 03/08/2022

Desc: Peaches; canned
Notes: 8/7/1997


INDIA


Bambino Agro Ind.Ltd.
Date Published : 05/24/2022
4e Surya Towers , Sardar Patel Road , Secunderabad, Telangana INDIA
04 A - - 06 Vermicelli
Date Published: 05/24/2022

Desc: Vermicelli

Nestle India
Date Published : 04/04/2022
100/101, World Trade Centre, Barakhamba Lane , New Delhi, INDIA
04 C - - 01 Noodles, Chow Mein
Date Published: 04/04/2022

Desc: Maggi Noodles

04 C - - 07 Noodles, Instant
Date Published: 04/04/2022

Desc: Maggi Noodles

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 04/04/2022

Desc: Maggi Noodles

Nestle India Limited
Date Published : 04/04/2022
Post Box No.1, Village Maulinguem (North) , Bicholim Taluka, Goa INDIA
04 C - - 01 Noodles, Chow Mein
Date Published: 04/04/2022

Desc: Maggi Noodles

04 C - - 07 Noodles, Instant
Date Published: 04/04/2022

Desc: Maggi Noodles

04 C - - 99 Noodles And Noodle Products, N.E.C.
Date Published: 04/04/2022

Desc: Maggi Noodles


ITALY


Giaguaro
Date Published : 05/17/2022
Via Ingegno Snc , Sarno, Salerno ITALY
24 F - - 50 Tomatoes (Fruit Used as Vegetable)
Date Published: 05/17/2022

Desc: Canned Tomatoes
Notes: Problem(s); mold; Added to DWPE on 4/4/1994


MEXICO


Candy Pop S.A. de C.V.
Date Published : 05/31/2022
Calle 26 Zona 1815 , Zona Industrial Zona Industrial, Guadalajara , Guadalajara, Jalisco MEXICO
33 C - - 06 Flavored Candy, Hard (Live Savers, Etc.), with Fruit (without Chocolate)
Date Published: 05/31/2022

Desc: All candy w/chili including Rebanaditos & Bolitochas
Notes: Published on 07/19/2004

33 E - - 01 Caramel Candy Bar, Hard, without Nuts and Fruit (without Chocolate)
Date Published: 05/31/2022

Desc: All candy w/chili including Rebanaditos & Bolitochas
Notes: Published on 07/19/2004

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: All candy w/chili including Rebanaditos & Bolitochas
Notes: Published on 07/19/2004

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/31/2022

Desc: All candy w/chili including Rebanaditos & Bolitochas
Notes: Published on 07/19/2004

EL AZTECA DULCES Y GOLOSINAS DE MEXICO SA DE CV
Date Published : 05/31/2022
Calzada Independencia Norte 4447 , Col. HUENTITAN EL BAJO , Guadalajara, Jalisco MEXICO
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: El Azteca Olla Chili Candy
Notes: Published on 08/03/2012

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Tamalindo Tamarind flavor candy
Notes: Published on 01/07/2014

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Chileta Sandia Watermelon Lollipop with Chili
Notes: Published on 4/18/2016

El Azteca De Mexico
Date Published : 05/31/2022
Las Flores No. 113 , Col. Victor Hugo , Zapopan, Jalisco MEXICO
33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Hot Candy Spoon
Notes: Published on 08/20/2010

33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Hot Candy Spoon
Notes: Published on 08/20/2010

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Hot Candy Spoon
Notes: Published on 08/20/2010

El Azteca Dulces Y Golosinas De Mexico
Date Published : 05/31/2022
Carretera Reynosa Km 2.5 , Zona Industrial , Matamoros, FN MEXICO
33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Chileta Sandia Watermelon Lollipop with Chili
Notes: Published on 04/18/2016

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Tamalindo Tamarind flavor candy
Notes: Published on 01/07/2014

Productos Chamoyada S.A. De C.V.
Date Published : 05/31/2022
Calle Jaime Nuno No.1815 Co. Cav , Reynosa, Fn MEXICO
33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: hard and soft candies containing chili pepper
Notes: Published on 03/18/1998

33 L - - 99 Soft Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: hard and soft candies containing chili pepper
Notes: Published on 03/18/1998

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: hard and soft candies containing chili pepper
Notes: Published on 03/18/1998

Productos Karla, S.A. de C.V.
Date Published : 05/31/2022
Carretera Guadalajara - Saltillo Km 187 , Tabasco , Col. Tabasco, Zacatecas MEXICO
33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Mangopers caramel lollipops with Chili
Notes: Published on 11/01/2013

33 C - - 99 Hard Candy with Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Tabasquenos caramel lollipops with Chili
Notes: Published on 11/01/2013

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Mangopers caramel lollipops with Chili
Notes: Published on 11/01/2013

33 E - - 99 Hard Candy without Nuts and Fruit, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Tabasquenos caramel lollipops with Chili
Notes: Published on 11/01/2013

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Tabasquenos caramel lollipops with Chili
Notes: Published on 11/01/2013

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Mangopers caramel lollipops with Chili
Notes: Published on 11/01/2013

33 S - - 06 Lollipop (without Chocolate)
Date Published: 05/31/2022

Desc: Mangopers w/Chili Hard Candy Lollipops
Notes: Published on 11/01/2013

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Tabasquenos caramel lollipops with Chili
Notes: Published on 11/01/2013

33 S - - 99 Candy Specialties, N.E.C. (without Chocolate)
Date Published: 05/31/2022

Desc: Mango Mangopers caramel lollipops with Chili
Notes: Published on 11/01/2013

Seradco S.A. De C.V.
Date Published : 05/17/2022
Medranos No 47col Aguilar , Mexico, MEXICO
36 C - - -- Honey
Date Published: 05/17/2022

Desc: Honey
Notes: 11/21/00; honey; metal wire; foreign object - filth