FDA WARNING_LETTER - MKK Imports - March 26, 2023

On March 26, 2023, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of MKK Imports, following previous inspections in 2018 and 2019, to determine compliance with Section 805 of the FD&C Act and 21 CFR part 1, subpart L. The inspection revealed significant violations, specifically that MKK Imports failed to develop, maintain, and follow an FSVP for any foods imported into the U.S., as required by Section 805 of the FD&C Act and 21 CFR 1.502(a). The FSVP regulation mandates importers perform risk-based activities to verify imported foods meet U.S. food safety standards. A Form FDA 483a FSVP Observations was issued at the conclusion of the inspection, but no response has been received from the firm. The FDA requires a written response within fifteen working days detailing specific corrective actions, including documentation of implemented FSVP records. Failure to adequately address these violations may 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.