Flores Produce, Inc.

Warning LetterOpen

Manuel Flores Lopez Owner Flores Produce, Inc. 1720 Melrose Ave Unit 4 Chula Vista , CA 91911-6541 United StatesFEI 3021304279Issued Jun 24, 2022Division of Southwest Imports

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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 3021304279.

Violations2

Issue DateJun 24, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Flores Produce, Inc.
Location: Manuel Flores Lopez Owner Flores Produce, Inc. 1720 Melrose Ave Unit 4 Chula Vista , CA 91911-6541 United States
FEI Number: 3021304279
Country: United States
Issue Date: June 24, 2022
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

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.

Flores Produce, Inc. FDA Warning Letter, June 24, 2022