MG GROUP USA – FDA Warning Letter, Aug 14, 2025

The FDA issued a Warning Letter to MG GROUP USA on October 23, 2025, following a Foreign Supplier Verification Program (FSVP) inspection on August 14, 2025, with additional inspections conducted from February 8-21, 2023, and September 9-16, 2024. The company was found non-compliant with section 805 of the Federal Food, Drug, and Cosmetic Act and its implementing FSVP regulation (21 CFR part 1, subpart L). The primary violation involves the company"s failure to develop, maintain, and follow an FSVP for foods imported into the United States. Specifically, MG GROUP USA lacked an FSVP for various products, including White Truffle Olive Oil, Fresh Summer Truffles, and Fresh Black Truffles. Despite a response to initial observations, the company did not provide documentation confirming the development or implementation of FSVPs for any imported foods. MG GROUP USA must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, such as copies of developed FSVPs and records demonstrating their implementation. Failure to adequately address these violations may result in further FDA actions, including refusal of admission for imported foods, detention without physical examination, and prohibition under the FD&C Act.