Gonzar Produce, LLC

Warning LetterOpen

Mr. Jose Alan Gonzalez Owner/Manager Gonzar Produce, LLC 2501 W. Military Hwy. Suite B52 McAllen , TX 78503 United States Gonzar.inc@gmail.comFEI 3018133040Issued Mar 3, 2025Division 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 3018133040.

Violations3

Issue DateMar 3, 2025

Product TypeOther

StatusOpen

Letter Details

Firm: Gonzar Produce, LLC
Location: Mr. Jose Alan Gonzalez Owner/Manager Gonzar Produce, LLC 2501 W. Military Hwy. Suite B52 McAllen , TX 78503 United States Gonzar.inc@gmail.com
FEI Number: 3018133040
Country: United States
Issue Date: March 03, 2025
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

Summary

Gonzar Produce, LLC, an importer of fresh produce including mangoes and guavas, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by federal law and regulation 21 CFR part 1, subpart L. During FDA inspections conducted in July 2023 and December 2024, investigators found that the company had not established an FSVP for any of the foods it imported, representing significant violations of section 805 of the Federal Food, Drug and Cosmetic Act. The company also failed to respond to the Form FDA 483a observations issued at the conclusion of the December 2024 inspection.

Gonzar Produce, LLC FDA Warning Letter, March 3, 2025