FDA 483 - YemenUSA Inc. - May 14, 2021

YemenUSA Inc. in Detroit, MI, was cited for severe deficiencies in its Foreign Supplier Verification Program (FSVP) during an FDA inspection. The firm failed to develop an FSVP for any foreign suppliers or imported foods, leading to the import of products, such as black pepper and razaki raisins, that were subject to refusal due to contamination with Salmonella and illegal pesticide residues, respectively. This indicates a significant lack of control over foreign suppliers and imported food safety.