FDA WARNING_LETTER - Wismettac Asian Foods, Inc. - October 13, 2020

The FDA issued a Warning Letter to Wismettac Asian Foods Inc. following FSVP inspections in 2020, initiated due to a Salmonella Stanley multi-state outbreak linked to the firm's Shirakiku brand Black Fungus (Kikurage). Samples confirmed Salmonella matching the outbreak strain. The inspections revealed significant non-compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L and section 805 of the FD&C Act). Key violations included the failure to evaluate foreign supplier performance (21 CFR 1.505) for Black Fungus, failure to develop and follow FSVPs for multiple products (21 CFR 1.502(a)), and an inadequate hazard analysis for Shiitake mushrooms (21 CFR 1.504(a)) that did not identify biological hazards requiring control. Additionally, the firm failed to adequately document corrective actions (21 CFR 1.508(a)), follow and document written procedures for approved suppliers (21 CFR 1.506(a)(1)), and document the basis for less-than-annual verification activities for serious hazards (21 CFR 1.506(d)(2)). The FDA considers Black Fungus a ready-to-eat food, requiring Salmonella to be addressed as a foreseeable hazard. The firm must take prompt corrective actions and respond within 15 working days with supporting documentation. Failure to comply may result in refusal of admission and detention without physical examination (DWPE) of imported foods, including Black Fungus already under specific import alerts.