FDA WARNING_LETTER - Selamta LLC - February 03, 2021

On May 7, 2021, the FDA issued a Warning Letter to Mr. Arega following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from January 27 to February 3, 2021, and an initial inspection on November 9, 2018. The inspection aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers to perform risk-based activities to verify imported food meets U.S. safety standards.

The firm was found non-compliant, specifically lacking an FSVP for Black Tea imported from Ethiopia, and for any other imported food products. This violates 21 CFR 1.502(a), which requires developing, maintaining, and following an FSVP. The firm acknowledged in a February 10, 2021, response that no FSVP had been developed but planned implementation within four to six months, and stated intent to complete FSPCA FSVP training.

Failure to address these violations may lead to refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is prohibited under Section 301(zz) of the FD&C Act. The firm must