FDA WARNING_LETTER - Caribbean Produce Exchange, LLC - March 06, 2024

The FDA issued a Warning Letter to Caribbean Produce Exchange, LLC following an FSVP inspection from February 27 to March 6, 2024, prompted by a multistate investigation into elevated lead levels in apple cinnamon fruit puree pouches from their foreign supplier, Austrofood S.A.S. of Ecuador. The product was subject to a Class 1 recall on October 29, 2023, and placed on Import Alert #99-42.

The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act. Specifically, the firm failed to: 1. Conduct a written hazard analysis for the imported WanaBana apple cinnamon puree, as required by 21 CFR 1.504. While a hazard analysis was later provided, its adequacy for future imports will be assessed. 2. Approve their foreign supplier, Austrofood, based on a documented evaluation of performance and risk, as required by 21 CFR 1.505(b). Although an approval form was submitted post-recall, its sufficiency for all imported products from Austrofood is pending further assessment. 3. Ensure foreign supplier verification activities provided adequate assurance that hazards were significantly minimized or prevented, as required by 21 CFR 1.506(c). Onsite audit reports provided did not sufficiently