GUILLERMO OSUNA – FDA Warning Letter, Mar 1, 2021

On February 23, 2021, through March 1, 2021, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Guillermo Osuna, with a prior onsite inspection on February 13, 2019. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The firm was found not in compliance with FSVP requirements for imported cucumber-lemon, hibiscus-jamaica, and lychee bottled waters from Envasadora La Suprema SA de CV, and for any other imported foods. Specifically, the firm failed to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). The firm did not respond to Form FDA 483a from either inspection. Failure to adequately address this violation may lead to refusal of admission of imported food products under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. A written response detailing corrective actions and supporting documentation is required within fifteen working days.