WISETRADE CORPORATION – FDA Warning Letter, Feb 15, 2023

On June 30, 2023, the FDA issued a Warning Letter to Wisetrade Corporation following a Foreign Supplier Verification Program (FSVP) inspection on February 15, 2023. The inspection, prompted by a recall of enoki mushrooms due to *Listeria monocytogenes* contamination, found the company non-compliant with 21 CFR Part 1, Subpart L.

Violations include: 1. Failure to obtain written assurances from foreign suppliers for imported foods (enoki, oyster, and shiitake mushrooms from various Republic of Korea suppliers), as required by 21 CFR 1.512(b)(3). The company only had assurance for one specific oyster mushroom import. 2. Failure to document corrective actions after a voluntary recall of enoki mushrooms from a Republic of Korea supplier on March 23, 2022, due to *Listeria monocytogenes* detection by the California Department of Public Health. This supplier was also placed on FDA Import Alerts #99-23 and #25-21 for *Listeria* contamination. Although the company stated it would cease importing enoki mushrooms, this action was not documented, violating 21 CFR 1.512(b)(4).

The FDA noted that no response to the Form FDA 483a issued on February 15, 2023, had