FDA WARNING_LETTER - YemenUSA Inc. - May 14, 2021

On July 22, 2021, the FDA issued a Warning Letter to YemenUSA Inc. following an FSVP inspection conducted from May 4 to May 14, 2021, at their Detroit, MI facility. The inspection aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L). The FDA found that YemenUSA Inc. is not in compliance with these requirements for foods imported, specifically black pepper powder and raisins from their foreign supplier, Yassin Spices, Yemen. This non-compliance constitutes a significant violation of section 805 of the FD&C Act. The firm was issued a Form FDA 483a, FSVP Observations, but no response had been received as of the letter's date. The FDA requires a written response within fifteen working days detailing corrective actions, including supporting documentation like a copy of their FSVP and implementation records. Failure to adequately address these violations may lead to further action, such as refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz). The letter also provided guidance regarding potential "very small importer" status and associated modified FSVP requirements under 21 CFR 1.512.