Ada Teff – FDA Warning Letter, Sep 22, 2022

On December 12, 2022, the FDA issued a Warning Letter to Ada Teff following a Foreign Supplier Verification Program (FSVP) inspection conducted from September 19-22, 2022, at their Garland, TX facility. A previous inspection occurred from May 5-21, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. safety standards.

The FDA found Ada Teff not in compliance with FSVP requirements for any imported foods, constituting significant violations of section 805 of the FD&C Act. Specifically, Ada Teff failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods.

Following the inspection, a Form FDA 483a, FSVP Observations, was issued. Ada Teff's October 4, 2022, email response, stating intent to "take a Class within 90 days," was deemed inadequate due to lack of documentation demonstrating enrollment or specific steps taken for FSVP compliance.

The FDA warned that failure to adequately address these violations could lead to refusal of admission for imported food under section 801(a)(3) of