As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters.
Warning letters often are not issued until a company has been given months to years to correct problems.Mariscos Procesados – CAMPRESA – S.A.
Rivas, NicaraguaThe U.S. Food and Drug Administration has issued a warning letter to Mariscos Procesados – CAMPRESA – S.
A., a seafood processing facility in Nicaragua, for failing to comply with federal seafood safety regulations. The violations, identified during an inspection from Aug.
12-16, 2024, include deficiencies in the company’s Hazard Analysis and Critical Control Point (HACCP) plan for frozen mahi-mahi fillets in vacuum packaging.The FDA determined that the company’s products are adulterated under the Federal Food, Drug, and Cosmetic Act because they were processed under conditions that could render them injurious to health. The letter, issued on Nov.
5, 2024, and posted recently outlines serious concerns related to food safety hazards, including the potential for scombrotoxin (histamine) formation and Clostridium botulinum toxin development.Critical violationsDuring the Foreign Remote Regulatory Assessment (FRRA), the FDA found that CAMPRESA’s HACCP plan failed to adequately address key food safety hazards:Lack of critical control point.
