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.
Reunipeche SAS
Le Port, La Reunion, France
The FDA issued a warning letter on Dec. 26, 2024, to Reunipeche SAS following an inspection on July 3-4, 2024, at its seafood processing facility in Le Port, La Reunion, France.
The inspection revealed serious violations of the seafood HACCP regulation, rendering the company’s whole fresh fish products adulterated under the Federal Food, Drug, and Cosmetic Act due to conditions that could make them injurious to health.
Critical violations
- Inadequate hazard analysis: The revised HACCP plan, dated July 17, 2024, failed to list pathogen growth and toxin formation as hazards for products intended for raw consumption. Hazards such as Listeria, parasites, histamine, and allergens were noted in a separate document but not included in the HACCP plan, risking inadequate controls.
- Inadequate critical limits: At the receiving critical control point (CCP), the critical limit was insufficient to control scombrotoxin (histamine) formation, lacking requirements for harvest vessel records to verify proper fish handling. At the storage CCP, the critical limit did not ensure fish were held at 40 degrees F (4.4 degrees C) or below with continuous temperature monitoring.
- Inadequate monitoring procedures: Monitoring at the receiving and processing CCPs was insufficient to control histamine formation. The FDA recommends examining at least 118 fish per lot at receiving and measuring internal temperatures of at least 12 fish during processing.
Additional concerns
The FDA noted that the HACCP plan did not identify the labeling step as a CCP to control undeclared allergens, increasing the risk of mislabeled products.
FDA action and next steps
Reunipeche responded on July 19, Sept. 16, and Sept. 24, 2024, with revised HACCP documents, but the FDA found these inadequate. The agency requested a written response within 15 working days of the December 2024 warning letter, including a revised HACCP plan, five consecutive days of monitoring records, and other documentation. Failure to comply could lead to refusal of entry for the company’s products into the U.S. and placement on Import Alert #16-120, allowing detention without physical examination.
The full warning letter can be viewed here.
Rey de los Camarones S.A.
Ciudad Sandino, Managua, Nicaragua
The FDA issued a warning letter on Dec. 23, 2024, to Rey de los Camarones S.A. following a Foreign Remote Regulatory Assessment (FRRA) from Aug. 26-30, 2024, at its seafood processing facility in Ciudad Sandino, Managua, Nicaragua. The assessment identified serious HACCP violations, rendering the company’s dried and salted sea cucumber products adulterated.
Critical violations
- Missing critical control point for drying: The HACCP plan did not include a CCP for the drying step to control biological pathogen growth, including Staphylococcus aureus. The company dries sea cucumbers at high temperatures or in the sun but lacks scientific validation to ensure a water activity of 0.85 or below, critical for preventing toxin formation.
- Failure to monitor fishing areas: The HACCP plan required monitoring the status of fishing areas for environmental chemicals and pesticides, but records from June 2024 showed only organoleptic exams of incoming sea cucumbers, with no documentation of fisherman or authority verifications or INPESCA letters confirming safe marine waters.
Additional concerns
The FDA emphasized that inadequate drying and lack of water activity testing could allow pathogen growth in products distributed at ambient temperatures with a shelf-life of several months.
FDA action and next steps
The company has not responded to the observations provided at the assessment’s conclusion. The FDA has requested a written response within 15 working days, detailing corrective actions. Non-compliance could result in refusal of entry for the company’s products into the U.S. and placement on Import Alert #16-120.
The full warning letter can be viewed here.
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