FDA WARNING_LETTER - Genpro Imports & Export Inc. - December 13, 2023

The FDA issued a Warning Letter to Genpro Imports & Exports Inc. following FSVP inspections on May 11 and December 13, 2023, which revealed significant non-compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The company imports foods such as summer squash, fresh ginger, and taro. Key violations include the failure to develop, maintain, and follow an adequate Foreign Supplier Verification Program (FSVP) as required by 21 CFR 1.502(a). The firm also failed to conduct a hazard analysis for each imported food, specifically fresh ginger from China, violating 21 CFR 1.504(a). Furthermore, Genpro Imports & Exports Inc. did not approve foreign suppliers based on proper evaluations and lacked written procedures for importing solely from approved suppliers, as mandated by 21 CFR 1.505(a), 1.505(b), and 1.506(a)(1), continuing to import from an unapproved supplier. An additional deficiency noted was the inadequate documentation of foreign supplier verification activities, particularly regarding onsite audits, failing to meet 21 CFR 1.506(e)(1)(i)(D) requirements. The FDA requires a written response within fifteen working days detailing corrective actions and providing supporting documentation. Failure to comply may result in refusal of admission for imported foods, detention without physical examination (DWPE), and prohibition of importation under federal law.