FDA Sends Warning Letter to Spanish Food Company Over Seafood HACCP Violations

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not made visible to the public until weeks or months after they are sent. Business owners have 15 days to respond to warning letters from the FDA. Warning letters are often only issued after a company has been given months or years to resolve problems.

Jolca, SA
Seville, Spain

The U.S. Food and Drug Administration has issued a warning letter to Jolca, SA, located in Huevar Del Aljarafe, Seville, Spain, for significant violations of the Hazard Analysis and Critical Control Point (HACCP) regulations for seafood. The letter, dated March 21, 2024, describes a Foreign Regulatory Assessment (FRRA) conducted at the company’s seafood processing facility from October 2 to October 11, 2023. The FDA inspection revealed multiple serious violations of HACCP regulations, including: are crucial for ensuring the safety of fish and fishery products.

Main violations:

1. Failure to address critical food safety hazards:
   • Formation of scombrotoxin (histamine) and S. aureus toxin: The HACCP plan of Jolca, SA for green olives stuffed with anchovies or tuna did not mention the dangers of histamine formation and the growth of Staphylococcus aureus (S. aureus) and the formation of toxins 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 the formation of histamine and toxins in the absence of proper time/temperature controls.
   • S. aureus toxin formation during cooking and fermentation of olives: 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 of particular concern because the 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 from undeclared allergens, particularly the anchovies and tuna, major allergens that require control measures to ensure proper labelling.
2. Inadequate implementation of the HACCP plan:
   • The Jolca, SA HACCP plan 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 legal requirements and compromises the safety of their seafood products.

FDA Response and Requirements:

The FDA has requested Jolca, SA to take immediate corrective action to address these significant violations. The company must submit documentation demonstrating that its HACCP plan has been revised and includes all necessary controls for the identified hazards, including critical limits, monitoring procedures and verification steps. In addition, the company must provide evidence that the revised HACCP plan has been properly implemented, including five consecutive days of completed monitoring data.

Failure to adequately address these violations could result in regulatory action, including denial of importation of Jolca, SA’s imported fish or fishery products into the United States, and placement without physical examination (DWPE).

The FDA also noted that the company must ensure compliance with processing and manufacturing recordkeeping requirements, including maintaining records of pH measurements and other critical factors to ensure product safety.

The full warning letter can be viewed here.

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