FDA WARNING_LETTER - AH USA Group Inc - October 09, 2024

On February 25, 2025, the FDA issued a Warning Letter to AH USA Group Inc. following inspections conducted from October 2-9, 2024, and August 25-30, 2022. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) under section 805 of the FD&C Act.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including specific unnamed products. This constitutes a significant violation of section 805 of the FD&C Act. The company's emailed response dated October 23, 2024, outlining plans to meet with suppliers, take an FSVP class, and noting receipt of certificates of analysis for preserved strawberry and rice vermicelli, was deemed inadequate due to a lack of supporting FSVP documentation.

The FDA also noted that while the company began hazard analyses for some products (e.g., durian cookies, mango wafers), these analyses were incomplete, failing to identify all known or reasonably foreseeable biological, chemical, and physical hazards as required by 21 CFR 1.504. Furthermore, meeting hazard analysis requirements alone is insufficient; the FSVP regulation also mandates foreign supplier performance evaluation (21 CFR 1.505) and verification activities (21 CFR