Import Alert 16-121
(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 # 16-121
Published Date: 10/26/2022
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Processed Seafood Products Due to E. Coli"
Reason for Alert:
The revision of this Import Alert (IA) dated 02/10/2022 updates the reason for alert, guidance section and charge code language. Changes to the import alert are bracketed by asterisks (***).
***The Division of Northeast Imports collected a sample of frozen cooked clam meat. Analysis by the Northeast Food and Feed Lab revealed excessive levels of E. coli.
The Center for Food Safety and Applied Nutrition (CFSAN) will support detention without physical examination (DWPE) in instances where excessively high levels of E. coli are found in processed seafood. These levels are indicative of product that has been processed under insanitary conditions, thereby creating a potential threat to the health of consumers. This meets the criteria established in the Regulatory Procedures Manual (RPM), Chapter 9, Subchapter - Detention without Physical Examination (DWPE).***
***The Division of Northeast Imports collected a sample of frozen cooked clam meat. Analysis by the Northeast Food and Feed Lab revealed excessive levels of E. coli.
The Center for Food Safety and Applied Nutrition (CFSAN) will support detention without physical examination (DWPE) in instances where excessively high levels of E. coli are found in processed seafood. These levels are indicative of product that has been processed under insanitary conditions, thereby creating a potential threat to the health of consumers. This meets the criteria established in the Regulatory Procedures Manual (RPM), Chapter 9, Subchapter - Detention without Physical Examination (DWPE).***
Guidance:
***Divisions may detain, without physical examination, shipments of identified products from firms on the Red List of this Import Alert.
All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement.
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. The purpose of this is to provide the Agency will confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). Therefore, it is expected the firm and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any corrective/preventive actions taken to ensure future shipments are in compliance. For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)".
If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be forward 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 the Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues on human food policy, or other any additional questions, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
***
All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement.
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. The purpose of this is to provide the Agency will confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). Therefore, it is expected the firm and/or an agent thereof will submit information outlining the firm's investigation into the root cause of the violation as well as any corrective/preventive actions taken to ensure future shipments are in compliance. For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)".
If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be forward 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 the Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues on human food policy, or other any additional questions, should be addressed to CFSAN, Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
***
Product Description:
Procesed seafood products
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 402(a)(4)]***
OASIS charge code: INSANITARY
OASIS charge code: INSANITARY
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)
HONG KONG SAR
Sun Wah Marine Products (Vietnam) Co., Ltd.
Date Published : 09/16/2009
Sun Wah Cold Storage Phase 1 , 215-239 Wu Shan Road
, Tuen Mun,
New Territories HONG KONG SAR
16 E - - 02 Clams
Date Published: 09/16/2009
Problems:
ESCHERICHIA : COLI (TYPICAL);
MEXICO
LA KALITA SC DE RL DE CV
Date Published : 10/26/2022
Mza 157 , Lago Meza Lote 3
, Guaymas,
Sonora MEXICO
16 J - - 01 Crab
Date Published: 10/26/2022
Desc: Crabmeat
VIETNAM
THANH AN CO., LTD.
Date Published : 09/16/2009
Lot 2, Street # 2, , Song Than 1 Industrial Park,
, Di An District,
VN-57 VIETNAM
16 E - - 02 Clams
Date Published: 09/16/2009
Desc: Frozen; Cooked
Notes: DWPE date - 1/7/2009
Problems:
ESCHERICHIA : COLI (TYPICAL);