FDA WARNING_LETTER - Export Guatemala Corporation - February 17, 2022

On February 17, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Export Guatemala Corporation, following a previous inspection on November 19-20, 2020. The inspection revealed that the company is not in compliance with section 805 of the FD&C Act and the implementing FSVP regulation in 21 CFR part 1 subpart L. The primary violation identified is the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods. This deficiency was noted as a repeat violation from the 2020 inspection. The company's March 2, 2022, response to the Form FDA 483a, stating efforts to obtain information from suppliers and requesting an extension, was deemed insufficient as it lacked specific corrective actions or documentation. The FDA emphasized that even if the company qualifies as a "very small importer" under 21 CFR 1.500, FSVP requirements, potentially modified under 21 CFR 1.512, still apply. Failure to adequately address these violations may lead to refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE), and prohibition under section 301(zz). The company is required to respond within 15 working days with specific corrective actions and supporting documentation.