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

Source: https://www.keypedia.com/records/warning_letter/gms-international-foods-inc/d675c862-4c8b-4719-8c5d-94fcc1246fe2

> FDA WARNING_LETTER for GMS International Foods Inc. on April 21, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: GMS International Foods Inc.
- Inspection Date: 2020-04-21
- Product Type: Food
- Office Name: Division of West Coast Imports Compliance Branch
- Summary: 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

## Related Officers

- [Assistant Commissioner](https://www.keypedia.com/people/dan-r-solis/0b0ce118-4e72-4d75-afdc-eadf7ff5a430)

Company: https://www.keypedia.com/companies/gms-international-foods-inc/15b7a91d-0e29-4a20-9e06-74dd773cbf55

Office: https://www.keypedia.com/offices/division-of-west-coast-imports-compliance-branch/c2ac6680-0cab-4f7f-83ac-1c2b18073c50