JR & Son World Trading LLC – FDA Warning Letter, Nov 10, 2020

On February 3, 2021, the FDA issued a Warning Letter to JR & Son World Trading LLC following a remote Foreign Supplier Verification Program (FSVP) inspection from October 14 to November 10, 2020, and a previous inspection on March 9, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The company was found non-compliant for imported Guava Paste, Coconut Water with Pulp, and Frozen Yellow Pepper Dices. Significant violations include: 1. Failure to document review and assessment of foreign supplier hazard analyses (21 CFR 1.504(d)). 2. Failure to verify and document that Coconut Water with Pulp, a low-acid canned food, was produced according to 21 CFR part 113 (21 CFR 1.502(b)(1)). 3. Failure to approve foreign suppliers based on performance and risk evaluation, and to document this approval (21 CFR 1.505(a), (b)). 4. Failure to establish and follow written procedures for importing only from approved foreign suppliers (21 CFR 1.506(a)(1)). 5. Failure to establish written procedures for appropriate foreign supplier verification activities for Guava Paste and Coconut Water with Pulp