Triple J Fresh, LLC

Warning LetterOpen

Mr. Juan Manuel Nazar Owner/President Triple J Fresh, LLC 501 N Bridge Street, PMB 944 Hidalgo , TX 78557 United StatesFEI 3012743405Issued Apr 25, 2022Division of Southwest Imports

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Violations1

Issue DateApr 25, 2022

Product TypeOther

StatusOpen

Letter Details

Firm: Triple J Fresh, LLC
Location: Mr. Juan Manuel Nazar Owner/President Triple J Fresh, LLC 501 N Bridge Street, PMB 944 Hidalgo , TX 78557 United States
FEI Number: 3012743405
Country: United States
Issue Date: April 25, 2022
Issuing Office: Division of Southwest Imports
Product Type: Other
Status: Open

Summary

Triple J Fresh, LLC, an importer of fresh produce including broccoli, coriander, and Persian limes, failed to establish a Foreign Supplier Verification Program (FSVP) as required by section 805 of the Federal Food, Drug, and Cosmetic Act. During FDA inspections conducted in January 2022 (and previously in May 2020), investigators found that the company had not developed, maintained, or followed any FSVP for the foods it imported, creating significant compliance gaps with 21 CFR part 1, subpart L. The company did not respond to the FDA 483a observations issued at the conclusion of the January inspection, compounding the violations.

Triple J Fresh, LLC FDA Warning Letter, April 25, 2022