La Yongjia Trade Co. – FDA Warning Letter, Feb 23, 2023

The FDA conducted an FSVP inspection at La Yongjia Trade Co. from February 15-23, 2023, due to *Listeria monocytogenes* findings in fresh enoki mushrooms imported from several foreign suppliers, many of whom are on Import Alerts 99-23 and 99-35. The inspection revealed the company was not in compliance with 21 CFR part 1 subpart L, specifically failing to develop, maintain, and follow an FSVP for any imported foods, including fresh enoki mushrooms from multiple named suppliers.

During the inspection, the company admitted to not having a hazard analysis, supplier evaluation procedures, or an FSVP for any imported foods. Documents provided were incomplete and not intended as FSVPs. This violates 21 CFR 1.502(a), which requires a written hazard analysis (21 CFR 1.504), foreign supplier evaluation (21 CFR 1.505), and verification activities (21 CFR 1.506). As an importer of "covered produce," the company must ensure suppliers meet produce safety standards (21 CFR part 112).

The FDA has not received a response to the Form 483 issued on February 23, 2023. Failure to correct these violations may result in refusal of admission for imported foods under section 801(a)(3) of