Import Alert 16-50
(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 # 16-50
Published Date: 08/21/2024
Type: DWPE
Import Alert Name:
"DETENTION WITHOUT PHYSICAL EXAMINATION OF MOLLUSCAN BIVALVE SHELLFISH"
Reason for Alert:
The revision of this Import Alert (IA) dated updates the name of the alert, the guidance section, product description, adds/updates charges, and PAF. Changes are bracketed by asterisks (***).
Examination of shipments of molluscan bivalve seafood from firms on the red list have been made. Salmonella, Vibrio cholera, other bacteria and/or viruses (e.g. Hepatitis A, Norwalk, etc.) were found, or epidemiological evidence associated the product with a food-borne illness outbreak.
Additionally, some shipments were labeled as "cooked" when in fact the product only received a minimal heat treatment in order to "open" the shells.
Examination of shipments of molluscan bivalve seafood from firms on the red list have been made. Salmonella, Vibrio cholera, other bacteria and/or viruses (e.g. Hepatitis A, Norwalk, etc.) were found, or epidemiological evidence associated the product with a food-borne illness outbreak.
Additionally, some shipments were labeled as "cooked" when in fact the product only received a minimal heat treatment in order to "open" the shells.
Guidance:
Divisions may detain, without physical examination, the specified product from the manufacturers on the Red List of this alert regardless of whether they are from a certified shipper under the National Shellfish Sanitation Program ***or sourced from a country with a regulatory control system determined equivalent by FDA and which is listed on the Interstate Certified Shellfish Shippers List (ICSSL). https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list***
***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
Firms (other than certified shippers) listed on the Red List of this import alert requesting removal should include documentation with sufficient evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved. In addition, 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 overcome, and that it may be appropriate to remove a firm and product from the Red List for this import alert. 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). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
Certified shellfish shippers listed on the Red List of this import alert seeking removal can be removed when inspected and found in-compliance by the country's competent authority with the National Shellfish Sanitation Program (NSSP) as set forth in a Compliance MOU between the United States and the signatory country or in accordance with an FDA equivalence determination of that country’s regulatory control system for bivalve molluscan shellfish. The competent authority can petition that the certified shellfish shipper be removed from this Import Alert by providing evidence to CFSAN, Office of Compliance. This includes products that have been found with bacterial or viral contamination and firms whose products have been associated with a food-borne illness outbreak. A copy of the petition and all relevant information supporting the petition should be forwarded to DIO.
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 via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@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 with regard to human food on policy, sample collection recommendations, or any additional questions, should be addressed to CFSAN/Division of Enforcement’s Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov***
***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
Firms (other than certified shippers) listed on the Red List of this import alert requesting removal should include documentation with sufficient evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved. In addition, 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 overcome, and that it may be appropriate to remove a firm and product from the Red List for this import alert. 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). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."
Certified shellfish shippers listed on the Red List of this import alert seeking removal can be removed when inspected and found in-compliance by the country's competent authority with the National Shellfish Sanitation Program (NSSP) as set forth in a Compliance MOU between the United States and the signatory country or in accordance with an FDA equivalence determination of that country’s regulatory control system for bivalve molluscan shellfish. The competent authority can petition that the certified shellfish shipper be removed from this Import Alert by providing evidence to CFSAN, Office of Compliance. This includes products that have been found with bacterial or viral contamination and firms whose products have been associated with a food-borne illness outbreak. A copy of the petition and all relevant information supporting the petition should be forwarded to DIO.
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 via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov.
Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@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 with regard to human food on policy, sample collection recommendations, or any additional questions, should be addressed to CFSAN/Division of Enforcement’s Food Adulteration Assessment Branch at (240) 402-1750 or CFSANEnforcement@fda.hhs.gov***
Product Description:
***Raw Molluscan Bivalve Shellfish***
Charge:
***For bacterial and/or viral (Salmonella, Vibrio cholera, Hepatitis A, Norwalk, etc.) violations:
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)]
OASIS charge code: POISONOUS***
AND/OR
***For Epidemiological Evidence (Association with a Food-borne Illness Outbreak) reviewed and supported by a subject matter expert:
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [Adulteration, Section 402(a)(4)]
OASIS charge code: MFR INSAN***
AND/OR
***For labeling violations:
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded, Section 403(a)(1)]
OASIS Charge code: FALSE***
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)]
OASIS charge code: POISONOUS***
AND/OR
***For Epidemiological Evidence (Association with a Food-borne Illness Outbreak) reviewed and supported by a subject matter expert:
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [Adulteration, Section 402(a)(4)]
OASIS charge code: MFR INSAN***
AND/OR
***For labeling violations:
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded, Section 403(a)(1)]
OASIS Charge code: FALSE***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
CHINA
DONGGANG HONGFENG FOODS FREEZE CO.,LTD
Date Published : 12/19/2013
NO. 177 Langdong Road , Donggang
, Dandong,
Liaoning CHINA
16 E - - 02 Clams
Date Published: 12/19/2013
Desc: Clams
Notes: Problem(s): Misbranded; PROBLEM: Raw product labeled as frozen cooked use OASIS charge code FALSE
Hainan Fruit Vegetable Food Allocation Co., Ltd.
Date Published : 09/18/2009
No. 21 Haiyu West Line , Xiuying Area Hikou
, Hainan,
CHINA
16 E - - 04 Mussels
Date Published: 08/21/2024
Desc: Mussels; Frozen; cooked on the half-shell
Notes: Problem(s): Misbranded; Problem- Product labeled as cooked DWPE date - 8/20/2002, use OASIS charge code FALSE
LONGHAI GELIN FOODS CO., LTD
Date Published : 09/18/2009
Gangwei Town
, Longhai City,
Fujian CHINA
16 E - - 04 Mussels
Date Published: 09/18/2009
Desc: Greenlip Mussels
Notes: Misbranded (raw product labeled as cooked) use OASIS charge code FALSE; DWPE date - 4/14/2003
Shanghai International Trade
Date Published : 09/18/2009
11 Th Floor 445 Jiangninglu
, Shanghaishi,
Shanghaishi CHINA
16 E - - 02 Clams
Date Published: 08/21/2024
Desc: Clams
Notes: Problem(s): Hepatitis A, Misbranded; Raw product labeled as cooked- use OASIS charge code FALSE; Hepatitis A use OASIS charge code POISONOUS; DWPE date - 12/18/2000
Taishan Guanglong Foodstuff Process Co., Ltd.
Date Published : 09/18/2009
Building 3 No. 1 , Guanghai; Xinchengkaifa Guanghaizhen Taishan
, Jiangmen,
Guangdong CHINA
16 E - - 04 Mussels
Date Published: 08/21/2024
Desc: Mussels dried; cooked
Notes: SALMONELLA use OASIS charge code POISONOUS; DWPE date - 9/15/2008
Problems:
SALMONELLA;
16 X - - 31 Mussels, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/21/2024
Desc: Mussels dried; cooked
Notes: SALMONELLA use OASIS charge code POISONOUS; DWPE date - 9/15/2008
Problems:
SALMONELLA;
Zhangzhou Foreign Trade Corp
Date Published : 09/18/2009
32 North Xinhua Road , Foreign Trade Blg.
, Zhangzhou,
Fujian CHINA
16 E - - 04 Mussels
Date Published: 02/01/2010
Desc: Green lip mussels
Notes: Problem(s): Misbranded; Misbranded raw product labeled as cooked use OASIS charge code FALSE; Shipper for Zhangzhou Gelin Seafoods; Longhai City; China. DWPE date - 4/14/2003
Zhanjiang Guolian Aquatic Products Co., Ltd
Date Published : 09/18/2009
Economic & Technological Development Dis , NO. 6 Yongping South Road
, Zhanjiang,
Guangdong CHINA
16 E - - 04 Mussels
Date Published: 08/21/2024
Desc: Mussels; frozen; cooked on the half-shell
Notes: Problem(s): Misbranded; Product labeled as frozen; cooked use OASIS charge code FALSE; Shipper for Hainan Fruit Vegetable Food Allocation Co.; Ltd.; Hainan; China. DWPE date - 8/20/2002
KOREA (THE REPUBLIC OF)
Manje Fishing Association Corporation
Date Published : 04/20/2022
135 Gimnyeong-Ro , Gujwa-Eup
, Jeju,
Jeju KOREA (THE REPUBLIC OF)
16 E - - 04 Mussels
Date Published: 04/20/2022
Desc: Mussels
Notes: Norovirus; Norovirus use OASIS charge code POISONOUS
MEXICO
Pescaderia Alvarez
Date Published : 04/08/2011
Blvd. Lopez Portillo 480 E/ Olivares Y , Lopez del Castillo; Col. Ley 57
, Hermosillo,
Mexico MEXICO
16 E - - 02 Clams
Date Published: 04/08/2011
Desc: Clams
Notes: Vibrio Cholera VIBRIO CHOLERA use OASIS charge code POISONOUS
Problems:
VIBRIO : CHOLERAE;
PHILIPPINES
De Oro Resources Inc.
Date Published : 09/15/2016
Suba Basbas
, Lapu-Lapu City,
CEBU PHILIPPINES
16 E - - 05 Scallops
Date Published: 09/15/2016
Desc: Scallops
Notes: Problem(s): Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
16 F - - 05 Scallops, Breaded
Date Published: 08/21/2024
Desc: Scallops
Notes: Problem(s); Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
16 G - - 05 Scallops, Cakes, Balls, Etc.
Date Published: 08/21/2024
Desc: Scallops
Notes: Problem(s); Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
16 O - - 05 Scallops, Hot Smoked, Shellfish
Date Published: 08/21/2024
Desc: Scallops
Notes: Problem(s); Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
16 R - - 05 Scallops, Imitation
Date Published: 08/21/2024
Desc: Scallops
Notes: Problem(s); Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
16 T - - 05 Scallops, Cold Smoked, Shellfish
Date Published: 08/21/2024
Desc: Scallops
Notes: Problem(s); Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
16 X - - 33 Scallops, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/21/2024
Desc: Scallops
Notes: Problem(s); Hepatitis A; Hepatitis A use OASIS charge code POISONOUS
PORTUGAL
Jose Arruda
Date Published : 09/18/2009
Hornal de Santa Luzia
, Ribeira Grande - Sao Miguel,
Pt-Nota PORTUGAL
16 E - - 07 Limpets
Date Published: 08/21/2024
Desc: Limpets
Notes: Salmonella use OASIS charge code POISONOUS; DWPE date - 3/29/2006
Problems:
SALMONELLA;
THAILAND
N S Super Enterprise Co Ltd
Date Published : 09/18/2009
109 Thua Pho Alley
, Pom Prap Sattru Phai,
Bangkok THAILAND
16 E - - 10 Cockles
Date Published: 08/21/2024
Desc: Cockles
Notes: VIBRIO CHOLERAE; SALMONELLA use OASIS charge code POISONOUS
Problems:
VIBRIO : CHOLERAE;
SALMONELLA;
VENEZUELA
Pescanova C.C.
Date Published : 09/18/2009
Calle Pagallo Galpon San Jose
, Guiria,
Sucre VENEZUELA
16 E - - 02 Clams
Date Published: 08/21/2024
Desc: Clams
Notes: SALMONELLA, coliforms use OASIS charge code POISONOUS; DWPE date - 4/21/1994
Problems:
SALMONELLA;
16 E - - 03 Oysters
Date Published: 08/21/2024
Desc: Oysters
Notes: SALMONELLA, coliforms use OASIS charge code POISONOUS; DWPE date - 4/21/1994
Problems:
SALMONELLA;
VIETNAM
Hua Heong Food Industries (Vietnam) CO., Ltd
Date Published : 09/18/2009
D3a-D3b Le Minh Xuan, Industrial Zone , Binh Chanh District
, Ho Chi Minh,
Vn-65 VIETNAM
16 E - - 02 Clams
Date Published: 08/21/2024
Desc: Clams; whole
Notes: Misbranded; (raw sold as cooked) use OASIS charge code FALSE; DWPE date - 2/14/2008
16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/21/2024
Desc: Clams; whole
Notes: Misbranded; (raw sold as cooked) use OASIS charge code FALSE; DWPE date - 2/14/2008
Kien Giang Ltd
Date Published : 09/18/2009
80/18a Ba Huyen Thanh Quan Dist. 3
, Ho Chi Minh City,
VIETNAM
16 E - - 02 Clams
Date Published: 09/18/2009
Desc: Blood Clams in shell; frozen; cooked
Notes: Problem: Misbranded- Frozen; raw sold as cooked; Salmonella use OASIS charge code POISONOUS; Misbranded- Frozen; raw sold as cooked use OASIS charge code FALSE; DWPE date - 3/30/2004
Problems:
SALMONELLA;
Nam Hai Company Ltd.
Date Published : 09/18/2009
An Lac Ward, Binh Tan District , 555, Kinh Duong Vuong St.
, Ho Chi Minh City,
Ho Chi Minh City VIETNAM
16 E - - 02 Clams
Date Published: 08/21/2024
Desc: Clams
Notes: SALMONELLA use OASIS charge code POISONOUS; DWPE date - 4/6/2007
Problems:
SALMONELLA;
16 X - - 30 Clams, Aquaculture Harvested Fishery/Seafood Products
Date Published: 08/21/2024
Desc: Clams
Notes: SALMONELLA use OASIS charge code POISONOUS; DWPE date - 4/6/2007
Problems:
SALMONELLA;
VUON LOI SEAFOOD IMPORT AND EXPORT CORPORATION
Date Published : 09/18/2009
835/12 Tran Hung Dao St.,
, Ho Chi Minh City,
Vn-65 VIETNAM
16 E - - 02 Clams
Date Published: 08/21/2024
Desc: Clams; frozen; cooked; whole
Notes: Problem(s): Misbranded; Misbranded (raw product labeled as frozen cooked) use OASIS charge code FALSE; SALMONELLA use OASIS charge code POISONOUS; DWPE date - 4/17/2006
Problems:
SALMONELLA;
16 E - - 10 Cockles
Date Published: 08/21/2024
Desc: Cockles; frozen; cooked; whole
Notes: Problem(s): Misbranded; Misbranded (raw product labeled as frozen cooked) use OASIS charge code FALSE; SALMONELLA use OASIS charge code POISONOUS; DWPE date - 4/17/2006
Problems:
SALMONELLA;
16 J - - 99 Crustaceans, N.E.C.
Date Published: 09/18/2009
Desc: Baby clams; frozen; cooked
Notes: Problem(s): Misbranded; Misbranded (raw product labeled as frozen cooked) use OASIS charge code FALSE; SALMONELLA use OASIS charge code POISONOUS; DWPE date - 4/17/2006
Problems:
SALMONELLA;