FDA WARNING_LETTER - Warbucks Seafood Ny Llc - April 01, 2024

On February 28 through April 1, 2024, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Warbucks Seafood NY LLC, following a previous inspection from September 29 to October 24, 2022. The inspection found the firm not in compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods. Although the firm indicated it might qualify as a "very small importer" under 21 CFR 1.500, it failed to document this status as required by 21 CFR 1.512(b)(1)(i). Even as a very small importer, the firm is still required to comply with 21 CFR 1.502, 1.503, and 1.509, and must obtain written assurance every two years that foreign suppliers comply with applicable food safety standards (21 CFR 1.512(b)(3)(i)).

The firm was issued a Form FDA 483a FSVP Observations on April 1,