Wismettac Asian Foods, Inc. Warning Letter Details

Summary

Wismettac Asian Foods, Inc. failed to comply with Foreign Supplier Verification Program (FSVP) requirements for imported food products, specifically Shirakiku brand Black Fungus (Kikurage/wood ear mushrooms). During an inspection triggered by a Salmonella Stanley multi-state outbreak investigation, the FDA determined that the company's imported black fungus was the likely source of the outbreak, with unopened packages confirmed to contain Salmonella Stanley matching the outbreak strain through whole-genome sequencing analysis. The company did not perform adequate risk-based verification activities to ensure their imported food met applicable U.S. food safety standards as required under section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1 subpart L.