FDA WARNING_LETTER - Patidar Trade, Inc. - September 10, 2021

The FDA issued a Warning Letter to Patidar Trade, Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 10 to September 10, 2021, which revealed significant violations of the Federal Food, Drug and Cosmetic Act (FD&C Act) section 805 and 21 CFR part 1, subpart L. The firm failed to develop, maintain, and follow an FSVP for any of the foods it imports, as required by 21 CFR 1.502(a). Additionally, Patidar Trade, Inc. did not provide documentation during the inspection to substantiate its claim of being a "very small importer" under 21 CFR 1.500, which would allow for modified FSVP requirements under 21 CFR 1.512. The FDA emphasized that if the firm operates as a very small importer, it must document this status per 21 CFR 1.512(b)(1)(i) and obtain written assurances from foreign suppliers as per 21 CFR 1.512(b)(3)(i). The firm was instructed to respond within 15 working days with corrective actions and supporting documentation. Failure to comply could result in refusal of admission for imported foods, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act. The letter also noted that some imported foods are already subject to DWPE under other Import Alerts, a factor to consider in supplier evaluation.