euphrates foods, llc – FDA Warning Letter, Sep 27, 2021

On December 23, 2021, the FDA issued a Warning Letter to Euphrates Foods, LLC dba Labeeb Alani Inc. following inspections on March 11-15, 2021, and September 7-27, 2021. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L) and section 805 of the FD&C Act.

The FDA found the company was not in compliance with FSVP requirements for imported foods. Specifically, Euphrates Foods, LLC failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). This was the second inspection where the company lacked any FSVP records.

The company's October 11, 2021, response acknowledged the absence of FSVP records and stated plans to take an FSVP course and submit FSVPs in 8-12 months. However, the FDA noted no documentation of immediate corrective actions.

Failure to adequately address these violations may lead to further FDA action, including refusal of admission of imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD