Pacific Exchange Distributors, LLC – FDA Warning Letter, Mar 27, 2024

On September 12, 2024, the FDA issued a Warning Letter to Pacific Exchange Distributors LLC following a Foreign Supplier Verification Program (FSVP) inspection on March 27, 2024, and previous inspections. The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP for most imported foods (21 CFR 1.502(a)). 2. Failure to conduct a written hazard analysis for each food type, or to document review and assessment of hazard analyses conducted by other entities, including verification that they were performed by a qualified individual (21 CFR 1.504(a), (d)). This was noted for Seasoned Radish Strips, Seasoned Plum, and Seasoned Mustard Greens. 3. Failure to approve foreign suppliers based on performance and food risk evaluations, and to document this approval (21 CFR 1.505(a), (b)) for the aforementioned products. 4. Failure to perform foreign supplier verification activities, including establishing and following written procedures, and determining/documenting appropriate activities and frequencies (21 CFR 1.506).

Additional comments highlighted concerns regarding hazard analyses not listing pesticides for fruits/vegetables, glass as