FDA WARNING_LETTER - 7333 LLC - December 20, 2021

On December 8-20, 2021, and February 10-19, 2021, the FDA inspected 7333 LLC for compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L). The inspection revealed the company is not in compliance with section 805 of the FD&C Act for imported foods including Scorched Barley, Frozen Dumpling, Macaroni, and Rice Noodle Soup.

The primary violation is the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). The company did not have an FSVP for any of the imported foods. A Form FDA 483a was issued on December 20, 2021.

The company's January 1, 2022, response was deemed inadequate because it estimated 8-12 months to complete the FSVP, provided untranslated documents, and included information for a red pepper powder product not covered in the inspection, lacking supporting documentation for corrective actions on the cited products.

Failure to address these violations may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section