Loading…
Manzela USA, LLC, a food and beverage importer based in McAllen, Texas, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation required under section 805 of the Federal Food, Drug, and Cosmetic Act. During a June 2022 inspection, FDA investigators found that the company did not develop, maintain, and follow required FSVPs for the foods it imported into the United States, as mandated by 21 CFR 1.502(a). The company's response to the inspection observations was deemed inadequate because it provided no supporting documentation or specific steps demonstrating corrective actions to achieve compliance with FSVP requirements.