FDA WARNING_LETTER - Grace Supply Inc. - September 06, 2023

The FDA issued a Warning Letter to Grace Supply Inc. on January 8, 2024, following remote Foreign Supplier Verification Program (FSVP) inspections conducted from August 16 to September 6, 2023, and February 13 to 16, 2023. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The FDA found Grace Supply Inc. not in compliance with FSVP requirements for most imported foods, except for banana chips from one specific supplier. Significant violations include: 1. Failure to develop, maintain, and follow an FSVP for most imported foods, as required by 21 CFR 1.502(a). 2. Inadequate hazard analysis for shredded frozen coconut, failing to identify and evaluate coconut as a potential chemical hazard (allergen) per 21 CFR 1.504(a). 3. Failure to conduct and document required supplier verification activities for extra hot snack mix, as per 21 CFR 1.506(e)(1). An audit was conducted at a parent company, not the direct supplier, and no sampling/testing results were provided. 4. Supplier verification activities for shredded frozen coconut did not adequately assure that hazards, specifically Salmonella (a SAHCODHA hazard), were minimized or prevented, as