FDA WARNING_LETTER - By George Food Specialties Inc. - November 25, 2024

On November 4-25, 2024, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of By George Food Specialties Inc. to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. The inspection revealed significant violations, indicating the firm is not in compliance with FSVP requirements. Specifically, the firm failed to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a) for any of the foods it imports. This fundamental deficiency means the company lacks the required risk-based activities to verify imported foods meet U.S. safety standards. The FDA issued a Form FDA 483a FSVP Observations, to which no response has been received. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) via Import Alert # 99-41, and is prohibited under section 301(zz) of the FD&C Act. The firm must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation, and explaining any delays.