Jerez Produce, Inc. Warning Letter Details

Summary

Jerez Produce, Inc., an importer of fresh produce, failed to comply with Foreign Supplier Verification Program (FSVP) requirements under section 805 of the Federal Food, Drug, and Cosmetic Act. During FDA inspections conducted in February 2023 and previously in August 2021, investigators found that the company did not develop, maintain, and follow an FSVP plan as required by 21 CFR 1.502(a) to verify that imported foods met applicable U.S. food safety standards. The company's response to FDA observations lacked supporting documentation demonstrating corrective actions or compliance measures, making it impossible for FDA to evaluate the adequacy of their proposed remediation.