FDA WARNING_LETTER - Thai Kee Trading Co - August 28, 2020

On January 8, 2021, the FDA issued a Warning Letter to Thai Kee Trading Co. following Foreign Supplier Verification Program (FSVP) inspections on August 26 and 28, 2020, and previously on September 28, 2017. The inspections found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandates risk-based activities to verify imported food meets U.S. safety standards.

Significant violations include: 1. Failure to conduct hazard analyses for imported products, specifically lacking a written hazard analysis for Thai Jasmine rice and failing to document review and assessment of foreign supplier hazard analyses for Tusino curing powder and canned mushroom vegetarian broth. (21 CFR 1.504) 2. Failure to establish and follow written procedures for approving foreign suppliers based on performance and risk evaluation, and to document these evaluations for Thai Jasmine rice, Tusino curing powder, and canned mushroom vegetarian broth. (21 CFR 1.506(a)(1), 1.505(a), 1.505(b)) 3. Failure to perform and document foreign supplier verification activities, including establishing and following procedures for determining appropriate activities and conducting/documenting them for the aforementioned products. (21 CFR 1.506(b), 1