FDA WARNING_LETTER - Mina Global Trading Corp - May 10, 2022

On August 8, 2022, the FDA issued a Warning Letter to Mina Global Trading Corp following inspections conducted from April 22 to May 10, 2022, and previously from April 12 to April 19, 2021. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) under section 805 of the FD&C Act.

The company, identified as a "very small importer," was found to be in significant violation of 21 CFR 1.512(b)(3)(i). Specifically, for imported foods like wafers with chocolate, sesame bars, and feta cheese, Mina Global Trading Corp failed to obtain written assurance, before importing and every two years thereafter, that foreign suppliers produce food in compliance with U.S. food safety standards, including sections 402, 403(w), 418, or 419 of the FD&C Act. The company admitted to not having FSVP documents, including these required written assurances.

The FDA has not received a response to the Form FDA 483a issued on May 10, 2022. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, and