Caribbean Produce Exchange, LLC

Warning LetterOpen

Felix Lopez General Manager Caribbean Produce Exchange, LLC Carr 869 Km 2.8 Interior Las Palmas Industrial Park Catano , PR 00962 United StatesFEI 2623509Issued Nov 4, 2024Division of Southeast Imports

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2623509.

Violations4

Issue DateNov 4, 2024

Product TypeOther

StatusOpen

Letter Details

Firm: Caribbean Produce Exchange, LLC
Location: Felix Lopez General Manager Caribbean Produce Exchange, LLC Carr 869 Km 2.8 Interior Las Palmas Industrial Park Catano , PR 00962 United States
FEI Number: 2623509
Country: United States
Issue Date: November 04, 2024
Issuing Office: Division of Southeast Imports
Product Type: Other
Status: Open

Summary

Caribbean Produce Exchange, LLC failed to comply with Foreign Supplier Verification Program (FSVP) requirements under 21 CFR part 1, subpart L while importing food products into the United States. The company did not adequately verify that foods from its foreign suppliers, specifically Austrofood S.A.S. of Ecuador, were produced in compliance with applicable U.S. food safety standards. The inspection was initiated following a multistate investigation that identified elevated lead levels in WanaBana brand apple cinnamon fruit puree pouches intended for infants as young as six months, which resulted in a Class 1 recall on October 29, 2023.

Caribbean Produce Exchange, LLC FDA Warning Letter, November 4, 2024