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: 06/02/2025
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Cooked Seafood Products Due to E. Coli"
Reason for Alert:
Note: The revision of this Import Alert (IA) dated 06/02/2025 updates the name of the alert, reason for alert, guidance, agency contacts, product description and charge codes. Changes to the import alert are bracketed by asterisks (***).
The Division of Northeast Imports collected a sample of frozen cooked clam meat, which was analyzed by the Northeast Food and Feed Lab and revealed excessive levels of Escherichia Coli (E.Coli).
***E. coli is a microbiological indicator of fecal contamination because it is commonly found in the intestines of warm-blooded animals including humans. The presence of E. coli in fish and fishery products indicates the product has been contaminated with human or animal feces and additional foodborne pathogens that can indicate a food safety hazard could be present. An effective cooking process by the manufacturer will eliminate E. coli and other pathogens. The presence of E. coli in a cooked ready-to-eat (RTE) finished product indicates that either the cooking process was inadequate or more likely fecal contamination from insanitary conditions occurred in the processing plant after cooking.***
The ***Human Foods Program (HFP) may support detention without physical examination (DWPE) in instances where E. coli is found in cooked fish and fishery products. Detection of E.coli in cooked fish and fishery products is*** 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, which was analyzed by the Northeast Food and Feed Lab and revealed excessive levels of Escherichia Coli (E.Coli).
***E. coli is a microbiological indicator of fecal contamination because it is commonly found in the intestines of warm-blooded animals including humans. The presence of E. coli in fish and fishery products indicates the product has been contaminated with human or animal feces and additional foodborne pathogens that can indicate a food safety hazard could be present. An effective cooking process by the manufacturer will eliminate E. coli and other pathogens. The presence of E. coli in a cooked ready-to-eat (RTE) finished product indicates that either the cooking process was inadequate or more likely fecal contamination from insanitary conditions occurred in the processing plant after cooking.***
The ***Human Foods Program (HFP) may support detention without physical examination (DWPE) in instances where E. coli is found in cooked fish and fishery products. Detection of E.coli in cooked fish and fishery products is*** 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 the products from firms identified on the Red List of this Import Alert.
*** Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).***
***NOTE: In cases where it appears that a product has been prepared, packed, or held under insanitary conditions, the appearance of a violation may not be resolved by reconditioning. If a firm is considering pursuing reconditioning, please contact the appropriate office at FDA.***
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 with 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. ***In addition to documentation related to root cause analysis and corrective/preventive actions, the firm and/or agent should submit analytical results from five consecutive non-violative shipments as confirmation of the continued effectiveness of implemented corrective actions.*** For further guidance on removal from DWPE, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be sent 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 Imports@fda.hhs.gov.
Questions or issues *** concerning human food with regard to policy, sample collection recommendations, or other any additional questions not directly related to a detained entry, should be addressed to Human Foods Program Imports Enforcement Branch at
HFP-OCE-Imports@fda.hhs.gov.***
*** ***.
*** Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).***
***NOTE: In cases where it appears that a product has been prepared, packed, or held under insanitary conditions, the appearance of a violation may not be resolved by reconditioning. If a firm is considering pursuing reconditioning, please contact the appropriate office at FDA.***
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 with 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. ***In addition to documentation related to root cause analysis and corrective/preventive actions, the firm and/or agent should submit analytical results from five consecutive non-violative shipments as confirmation of the continued effectiveness of implemented corrective actions.*** For further guidance on removal from DWPE, refer to FDA’s Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from DWPE under this Import Alert, all relevant information supporting the request should be sent 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 Imports@fda.hhs.gov.
Questions or issues *** concerning human food with regard to policy, sample collection recommendations, or other any additional questions not directly related to a detained entry, should be addressed to Human Foods Program Imports Enforcement Branch at
HFP-OCE-Imports@fda.hhs.gov.***
*** ***.
Product Description:
***Cooked*** seafood products
Charge:
***The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act 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) of the FD&C Act]
OASIS charge code: FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(1) of the FD&C Act in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [INSANITARY MANUFACTURING, PROCESSING OR PACKING, Section 801(a)(1) of the FD&C Act]
OASIS CHARGE CODE: MFR INSAN
AND***
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act 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) of the FD&C Act]
OASIS charge code: INSANITARY
OASIS charge code: FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(1) of the FD&C Act in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [INSANITARY MANUFACTURING, PROCESSING OR PACKING, Section 801(a)(1) of the FD&C Act]
OASIS CHARGE CODE: MFR INSAN
AND***
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act 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) of the FD&C Act]
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);