Baits and Sea Foods, S.A.

Warning LetterOpen

Mr. Ramiro J. Saborio Director of Operations Baits and Sea Foods, S.A. KM 25 Tipitapa-Masaya Highway Parque Industrial Astro, Nave 24C Tipitapa , Managua NicaraguaIssued Jun 30, 2023Center for Food Safety and Applied Nutrition (CFSAN)

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

Violations6

Issue DateJun 30, 2023

Product TypeFood & Beverages

StatusOpen

Letter Details

Firm: Baits and Sea Foods, S.A.
Location: Mr. Ramiro J. Saborio Director of Operations Baits and Sea Foods, S.A. KM 25 Tipitapa-Masaya Highway Parque Industrial Astro, Nave 24C Tipitapa , Managua Nicaragua
FEI Number: N/A
Country: Nicaragua
Issue Date: June 30, 2023
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Food & Beverages
Status: Open

Summary

Baits and Sea Foods, S.A., a seafood processing facility in Nicaragua, was found to have serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations during an FDA remote assessment in May 2023, rendering their fresh and frozen histamine-forming products (including mahi-mahi) adulterated. The company's HACCP plan failed to identify critical food safety hazards required by regulation, specifically omitting Clostridium botulinum growth and toxin formation, and undeclared allergens as hazards for their frozen, vacuum-packaged wild-caught mahi-mahi products. The firm did not respond to discussion items raised by the FDA investigator at the conclusion of the assessment.

Baits and Sea Foods, S.A. FDA Warning Letter, June 30, 2023