Grupo VPAS C.A.

Warning LetterOpen

Mr. Antonio J. Strocchi President Grupo VPAS C.A. Urb. Los Ruices Sur, Trieste Local Galpon S/N Caracas 1071 , Miranda Venezuela aj.strocchia@vpasgrupo.com e.galicia@vpasgrupo.comIssued Oct 17, 2024Human Foods Program

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations4

Issue DateOct 17, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Grupo VPAS C.A.
Location: Mr. Antonio J. Strocchi President Grupo VPAS C.A. Urb. Los Ruices Sur, Trieste Local Galpon S/N Caracas 1071 , Miranda Venezuela aj.strocchia@vpasgrupo.com e.galicia@vpasgrupo.com
FEI Number: N/A
Country: Venezuela
Issue Date: October 17, 2024
Issuing Office: Human Foods Program
Product Type: Food & Beverages
Status: Open

Summary

Grupo VPAS C.A., a Venezuelan seafood processor, was cited for serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) during a Foreign Remote Regulatory Assessment conducted January 22-26, 2024. The company's HACCP plan for fresh-frozen, IQF Medregal fillet products failed to comply with regulatory requirements, rendering the products adulterated under the Federal Food, Drug and Cosmetic Act. The FDA requested an English translation of the company's February 2024 response documentation on April 22, 2024, but received no response and proceeded with evaluation using automated translation tools.

Grupo VPAS C.A. FDA Warning Letter, October 17, 2024