FDA WARNING_LETTER - WCS Trading, Inc. - May 26, 2020

WCS Trading Inc. received an FDA Warning Letter following remote Foreign Supplier Verification Program (FSVP) inspections conducted from May 14-26, 2020, and previously on September 12, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L, which mandates importers perform risk-based activities to ensure imported food meets U.S. safety standards.

The company was found non-compliant for imported products including dried crushed chili, dried black fungus, and dried mushrooms from specific foreign suppliers. Significant violations included: 1. Failure to document review and assessment of hazard analyses conducted by their consultant, as required by 21 CFR 1.504(d). 2. Failure to provide documentation of foreign supplier performance evaluation and approval for dried black fungus and dried mushrooms from a specific supplier, as required by 21 CFR 1.505. 3. Failure to establish written procedures for and document the determination and performance of appropriate foreign supplier verification activities for crushed chili, dried mushrooms, and dried black fungus, as required by 21 CFR 1.506. Although third-party reports were obtained, the determination of their adequacy was not documented.

The FDA requires prompt corrective action. Failure to comply may result in refusal of admission for the implicated products under Section 801