(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 Name:
Reason for Alert:
***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).***
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
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