FDA WARNING_LETTER - GMS International Foods Inc. - April 21, 2020

On April 15-17 and 19-21, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of GMS International Foods Inc., following an initial onsite inspection on April 23, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found the firm not in compliance with FSVP requirements for imported products including Pran Puffed Rice, Pran Kalizera Rice, and Pran Flattened Rice from their foreign supplier. Specifically, the firm failed to develop, maintain, and follow an FSVP for these products, violating 21 CFR 1.502(a).

Although the firm provided HACCP plans for some products in response to a Form FDA 483a, they did not provide documentation of reviewing and assessing the foreign supplier's hazard analysis (21 CFR 1.504(d)), evaluating foreign supplier performance and risk (21 CFR 1.505(a)), or documenting supplier approval (21 CFR 1.505(b)). Furthermore, the firm lacked documented written procedures for approving foreign suppliers and conducting verification activities (21 CFR 1.506(a)(1), 1.506(b)). The firm also did not provide supporting documentation to qualify as