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, Nicaragua
The 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 violations
During 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 for storage: The company did not include a critical control point (CCP) to monitor the storage of mahi-mahi fillets in ice before processing and freezing. Without proper temperature controls during storage, there is an increased risk of histamine formation, which can lead to foodborne illness.
Failure to monitor fish at receiving: The HACCP plan did not require verification that fish were properly iced or held at or below 4.4 degrees C during transit to the facility. As a secondary processor receiving whole, eviscerated mahi-mahi, CAMPRESA is responsible for ensuring temperature controls were maintained throughout transportation.
Improper labeling of vacuum-packaged fish: The company’s labels for frozen, vacuum-packaged mahi-mahi fillets lacked the required “Keep Frozen” and thawing instructions. Without these warnings, there is a risk that consumers or retailers may store the product improperly, potentially leading to Clostridium botulinum toxin formation.
FDA action and next steps
At the conclusion of the assessment, the FDA requested corrective actions from the company. CAMPRESA submitted responses on Aug. 23 and Sept. 30, 2024, including a revised HACCP plan and supporting documentation. However, the FDA found the company’s response inadequate and issued the warning letter.
Failure to address the violations could result in further regulatory action, including the refusal of the company’s frozen mahi-mahi fillets for entry into the United States and placement on Import Alert #16-120, subjecting future shipments to detention without physical examination.
The full warning letter can be found here.
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