The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.
Jolca, S.A.
Sevilla, Spain
The U.S. Food and Drug Administration has issued a warning letter to Jolca, S.A., based in Huevar Del Aljarafe, Sevilla, Spain, for significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. The letter, dated March 21, 2024, describes a Foreign Regulatory Assessment (FRRA) conducted at the company’s seafood processing facility from Oct. 2 -11, 2023. The FDA’s inspection revealed multiple serious violations of the HACCP regulation, which are critical for ensuring the safety of fish and fishery products.
Key violations:
- Failure to address critical food safety hazards:
- Scombrotoxin (histamine) and S. aureus toxin formation: Jolca, S.A.’s HACCP plan for green olives stuffed with anchovy or tuna failed to list the hazards of histamine formation and Staphylococcus aureus (S. aureus) growth and toxin formation associated with the salted anchovies, tuna in oil, and natural tuna used in the products. The addition of water to these ingredients during processing can affect their water activity, creating conditions conducive to histamine and toxin formation in the absence of proper time/temperature controls.
- S. aureus toxin formation during olive cooking and fermentation: The company’s hazard analysis and HACCP plan did not identify the risk of S. aureus toxin formation during the cooking and fermentation process of the olives. This hazard is particularly concerning as S. aureus toxin is heat-stable and would not be eliminated by subsequent thermal processing.
- Undeclared allergens: The company’s HACCP plan failed to identify the risk of undeclared allergens, specifically the anchovies and tuna, which are major allergens requiring control measures to ensure proper labeling.
- Inadequate HACCP plan implementation:
- The HACCP plan provided by Jolca, S.A. lacked critical components such as critical limits, monitoring procedures, monitoring records and verification procedures for the identified critical control points. These deficiencies indicate that the company’s HACCP plan does not meet the regulatory requirements and puts the safety of their seafood products at risk.
FDA’s response and requirements:
The FDA has requested Jolca, S.A. to take immediate corrective actions to address these significant violations. The company must submit documentation demonstrating that their HACCP plan has been revised to include all necessary controls for the identified hazards, including critical limits, monitoring procedures, and verification steps. Additionally, the company must provide evidence that the revised HACCP plan has been properly implemented, including five consecutive days of completed monitoring records.
Failure to adequately address these violations may lead to regulatory actions, including the refusal of admission of Jolca, S.A.’s imported fish or fishery products into the United States and placing them on detention without physical examination (DWPE).
The FDA also noted that the company must ensure compliance with the processing and production records requirements, including maintaining records of pH measurements and other critical factors to ensure product safety.
The full warning letter can be viewed here.
(To sign up for a free subscription to Food Safety News, click here.)