FDA WARNING_LETTER - Kuzmir Imports Inc. - March 23, 2022

On September 13, 2022, the FDA issued a Warning Letter to Kuzmir Imports Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from March 10-23, 2022. Previous inspections occurred in April-May 2020 and May 2019. The inspection found the company non-compliant with 21 CFR part 1, subpart L, and section 805 of the FD&C Act for imported mini soup croutons onion garlic, nougat spread, and cashews.

Significant violations include: 1. Failure to conduct a hazard analysis for each imported food to determine hazards requiring control, as required by 21 CFR 1.504(a). The company did not document a hazard analysis, despite providing some related documents. 2. Failure to approve foreign suppliers based on an evaluation of performance and food risk, and to document this approval, as required by 21 CFR 1.505(a) and (b). The company did not document evaluation of supplier performance or risk, nor approval, despite providing some certificates. 3. Failure to perform and document foreign supplier verification activities, and to establish written procedures for these activities, as required by 21 CFR 1.506. The company did not document determination or performance of appropriate verification activities, or retain documentation of such determinations.