FDA WARNING_LETTER - Nassif Wholesale LLC - January 31, 2020

On January 31, 2020, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection at Nassif Wholesale LLC, located at 3330 2nd Avenue N, Suite 8, Palm Springs, FL 33461-3651. The inspection determined non-compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The firm failed to develop, maintain, and follow FSVPs for sesame seeds and tahini imported from (b)(4), tahini imported from (b)(4), and semolina imported from (b)(4). This constitutes a significant violation of the FSVP regulation. A Form FDA 483a, FSVP Observations, was issued, but no response has been received.

Additionally, the facility's registration was canceled, violating section 415 of the FD&C Act and 21 CFR Part 1, Subpart H, which mandates renewal between October 1 and December 31 of even-numbered years. Failure to register is a prohibited act under section 301(dd) of the FD&C Act.

The FDA requires prompt corrective action. Failure to comply may result in refusal of admission for the imported products under section 801