AKT Trading Inc. – FDA Warning Letter, Dec 15, 2023

On November 6 & 13, and December 15, 2023, the FDA inspected AKT Trading Inc. for compliance with the Foreign Supplier Verification Programs (FSVP) regulation (21 CFR part 1, subpart L). Previous inspections occurred in January 2018 and June-August 2020.

The inspection revealed significant violations for imported processed enoki mushrooms, processed shitake mushrooms, dried enokitake mushrooms, and prepared bamboo shoots.

Key violations include: 1. Failure to consider the foreign supplier's performance, including compliance with applicable FDA food safety regulations (e.g., 21 CFR parts 108 and 114 for acidified foods like prepared bamboo shoots), as required by 21 CFR 1.505(a)(1)(iii). The company's responses dated December 27, 2023, and January 10, 2024, did not provide documentation of corrective actions. 2. Failure to establish written procedures for appropriate supplier verification activities (21 CFR 1.506(b)) and to document the determination of appropriate activities and their frequency (21 CFR 1.506(d)). While FSVPs included supplier approval and food safety plans, they lacked documentation of verification activity determination.

The FDA noted that the provided audit reports for certain products should be promptly reviewed