FDA WARNING_LETTER - FUTURE BEST TRADING INC - July 05, 2024

On October 10, 2024, the FDA issued a Warning Letter to Future Best Trading Inc. following a Foreign Supplier Verification Programs (FSVP) inspection on July 3 and 5, 2024. The inspection, initiated due to the detection of *Listeria monocytogenes* in fresh Enoki Mushrooms imported by the company on May 6, 2024, revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L).

The primary violation cited is the failure to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). The company did not have an FSVP for any imported foods, including covered produce like Enoki Mushrooms, which must meet U.S. food safety standards (21 CFR part 112).

Although the company provided documents in response to the Form FDA 483a, they did not explain how these documents met FSVP requirements. The provided documents, including "FSVP for Enoki and King Oyster" and "FSVP for Mushroom from (b)(4)," were undated and lacked documentation of review or approval by a qualified individual (21 CFR 1.503(a)). Other documents were in a foreign language without translation, and the company did not demonstrate review or assessment of any submitted records.