FDA WARNING_LETTER - Maliba African Market Corp. - August 25, 2022

On August 18-25, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Maliba African Market Corp., following a previous inspection in 2021. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The FDA found the firm not in compliance with FSVP requirements for imported foods. The primary violation identified was the failure to develop, maintain, and follow an FSVP as mandated by section 805 of the FD&C Act and 21 CFR 1.502(a) for any imported food products. The firm indicated it might qualify as a "very small importer" under 21 CFR 1.500; if so, it must document this status per 21 CFR 1.512(b)(1)(i) and still comply with specific FSVP requirements, including obtaining biennial written assurances from foreign suppliers regarding compliance with U.S. food safety standards (21 CFR 1.512(b)(3)(i)). The firm received a Form FDA 483a but has not responded. Maliba African Market Corp. must respond within fifteen working days, detailing corrective actions, providing supporting documentation, and explaining any delays. Failure to address these significant violations could result in refusal of admission for imported foods, detention without physical examination, and prohibition of importation under the FD&C Act.