Rey de los Camarones S. A.

Warning LetterOpen

Mr. Jianwei Rong General Manager/Owner Rey de los Camarones S. A. Kilometer 9 Of The New Road to Leon In Front of the New York Motel, Barrio Xavier Gruta Ciudad Sandino , Managua Nicaragua (b)(6)Issued Dec 23, 2024Human Foods Program

View Letter

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

Violations3

Issue DateDec 23, 2024

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Rey de los Camarones S. A.
Location: Mr. Jianwei Rong General Manager/Owner Rey de los Camarones S. A. Kilometer 9 Of The New Road to Leon In Front of the New York Motel, Barrio Xavier Gruta Ciudad Sandino , Managua Nicaragua (b)(6)
FEI Number: N/A
Country: N/A
Issue Date: December 23, 2024
Issuing Office: Human Foods Program
Product Type: Food & Beverages
Status: Open

Summary

Rey de los Camarones S.A., a seafood processing facility in Nicaragua, was cited for serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA inspection in August 2024. The company failed to conduct a required hazard analysis and establish a compliant HACCP plan with identified critical control points as mandated by 21 CFR Part 123, rendering their dried and salted sea cucumber products adulterated. The FDA determined the products may have been prepared, packed, or held under unsafe conditions that could injure health, and the company had not responded to the inspection observations at the time the warning letter was issued.

Rey de los Camarones S. A. FDA Warning Letter, December 23, 2024