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: 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 c.
