FDA WARNING_LETTER - Cheshni Foods LLC - April 28, 2023

The FDA conducted an FSVP inspection of Cheshni Foods LLC from March 22 to April 28, 2023, finding significant non-compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L. The firm failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by 21 CFR 1.502(a). Although the firm indicated it might qualify as a "very small importer," it did not document this status per 21 CFR 1.512(b)(1)(i) and failed to obtain necessary written assurances from foreign suppliers regarding compliance with U.S. food safety standards, including sections 402, 403(w), 418, or 419 of the FD&C Act, as mandated by 21 CFR 1.512(b)(3)(i). No response was received to the Form FDA 483a issued. The FDA requires a written response within 15 working days detailing specific corrective actions, supported by documentation of FSVP development and implementation. Failure to adequately address these violations could result in severe business implications, including refusal of admission for imported foods under section 801(a)(3), detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.