FDA WARNING_LETTER - Jolca, S.A. - October 11, 2023

The FDA issued a Warning Letter to a seafood processing facility in Huevar De Aljarafe, Sevilla, Spain, following a Foreign Regulatory Assessment conducted from October 2-11, 2023. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their ready-to-eat cold smoked salmon products adulterated.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan:** The firm's HACCP plan for green olives stuffed with anchovy or tuna failed to list critical food safety hazards. * **Scombrotoxin (histamine) and *Staphylococcus aureus* (S. aureus) growth and toxin formation:** These hazards were not identified for salted anchovies, tuna in oil, and natural tuna, especially with the addition of water affecting water activity. The firm's internal histamine specifications also allowed levels considered adulterated by FDA (50 ppm or more). * ***S. aureus* growth and toxin formation in olives:** The hazard analysis failed to identify *S. aureus* growth and toxin formation during the (b)(4) step for olives cooked and fermented in underground tanks, where temperature controls are critical. * **Undeclared major food allergens:** Despite considering allergens, the HACCP plan did not identify undeclared finfish allergens (anchovies, tuna