Lempira Distribution LLC

Warning LetterOpen

Mr. Carlos Vigil-Arrieta President Lempira Distribution LLC 8519 NW 72nd St. Miami , FL 33166-2349 United StatesFEI 3012123098Issued Nov 3, 2021Division of Southeast Imports

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Violations1

Issue DateNov 3, 2021

Product TypeOther

StatusOpen

Letter Details

Firm: Lempira Distribution LLC
Location: Mr. Carlos Vigil-Arrieta President Lempira Distribution LLC 8519 NW 72nd St. Miami , FL 33166-2349 United States
FEI Number: 3012123098
Country: United States
Issue Date: November 03, 2021
Issuing Office: Division of Southeast Imports
Product Type: Other
Status: Open

Summary

Lempira Distribution LLC, a food and beverage importer in Miami, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) required to verify that imported foods meet U.S. safety standards. During inspections conducted in June-July 2021 and previously in December 2017, the FDA found the company had not established adequate FSVP documentation for its products and did not provide sufficient details or copies of FSVPs despite claiming to be developing them. The company's failure to implement a compliant FSVP program for each product represented a significant violation of section 805 of the Federal Food, Drug, and Cosmetic Act.

Lempira Distribution LLC FDA Warning Letter, November 3, 2021