NAFTA Distributors Inc. – FDA Warning Letter, Feb 21, 2023

On February 7-21, 2023, the FDA inspected NAFTA Distributors Inc. regarding compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L). A previous inspection occurred July 17-19, 2018. The recent inspection found significant violations, indicating non-compliance with section 805 of the FD&C Act. A Form FDA 483a FSVP Observations was issued on February 21, 2023, to which no response has been received.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a). 2. Failure to conduct or document review and assessment of hazard analyses for imported foods (e.g., mega marshmallows, hot sauce), as required by 21 CFR 1.504(a) and (d). 3. Failure to approve foreign suppliers based on documented evaluations of performance and risk, as required by 21 CFR 1.505(a) and (b), and 1.506(a)(1). 4. Failure to document foreign supplier verification activities, including determination of appropriate activities and frequencies, and documentation of site visits or third-party audit reviews, as required by 21 CFR 1.