FDA WARNING_LETTER - Dara Food LLC - March 14, 2022

On February 17 – March 14, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Dara Food LLC, following a previous inspection on December 9, 2019. The inspection revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, as the company failed to develop, maintain, and follow an FSVP for any imported foods.

Specifically, Dara Food LLC did not conduct a written hazard analysis (21 CFR 1.504), evaluate foreign supplier performance (21 CFR 1.505), or conduct foreign supplier verification activities (21 CFR 1.506). Export certificates provided by the company were not considered an adequate FSVP. The company acknowledged not having a hazard analysis, supplier evaluation procedures, or verification procedures.

The FDA issued a Form FDA 483a FSVP Observations. A subsequent email from Dara Food LLC on March 30, 2022, acknowledged receipt of the forms but did not include any corrective actions.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement on detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz)