FDA WARNING_LETTER - GW FOOD USA Inc. - December 02, 2021

On March 9, 2022, the FDA issued a Warning Letter to GW FOOD USA Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from November 30 to December 2, 2021, and a previous inspection on May 7-8, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to ensure imported food meets U.S. safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). During the inspection, records provided for a foreign supplier were in a foreign language, and the English translation generated via internet software did not match the foreign supplier's name, preventing evaluation of their adequacy or applicability to the FSVP.

The FDA noted that GW FOOD USA Inc. might qualify as a "very small importer" under 21 CFR 1.500. If so, they must document this status and comply with modified requirements, including obtaining written assurance from foreign suppliers regarding compliance with U.S. food safety standards.

Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement