C K Frozen Fish and Food Inc. Warning Letter Details

Summary

C K Frozen Fish and Food Inc., an importer of frozen fish and food products, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by federal regulations, creating compliance failures under section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. During an inspection conducted from February through March 2023, the FDA found that the company did not develop, maintain, or follow the required FSVP to verify that imported foods met applicable U.S. food safety standards. The company's response to FDA observations was inadequate, providing only a generic commitment to corrective action without detailing specific remedial steps or implementation timelines.