Flores Produce, Inc. Warning Letter Details

Summary

Flores Produce, Inc., a food importer based in Chula Vista, California, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation required under Section 805 of the Federal Food, Drug, and Cosmetic Act. Specifically, the company did not develop, maintain, and follow an FSVP for papayas imported from a foreign supplier, as mandated by 21 CFR 1.502(a). The FDA conducted inspections in October 2020 and March 2022, identifying these significant violations, and the company failed to respond to the Form FDA 483a observations issued on March 11, 2022.