FDA WARNING_LETTER - Fitsum Ghebremichael Amare - June 24, 2021

The FDA issued a Warning Letter to Fitsum Ghrebremichael Amare following Foreign Supplier Verification Program (FSVP) inspections on May 13, June 2, and June 24, 2021, and previously on June 11-12, 2019. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for imported foods, including Teff Grain and Brown Teff Grain from various foreign suppliers. This violates section 805 of the FD&C Act and 21 CFR 1.502(a). The FDA noted no response was received to the Form FDA 483a issued on June 24, 2021.

The letter also highlighted that if the importer qualifies as a "very small importer" under 21 CFR 1.500, they must document this status per 21 CFR 1.512(b)(1)(i) and comply with modified requirements, including obtaining written assurance from foreign suppliers every two years regarding compliance with U.S. food safety standards (21 CFR 1.512(b)(3)(i)). Additionally, the importer must provide their name, email, and a unique facility identifier (DUN