FDA WARNING_LETTER - Pesca Fina, S.A.

On April 4, 2017, an FDA inspection of a U.S. importer revealed that Pesca Fina, S.A. was supplying fresh wild-caught whole, eviscerated yellowtail tuna. The FDA collected Pesca Fina's HACCP plan for this product, which demonstrated serious deviations from the seafood HACCP regulation (21 CFR Part 123). This renders the firm's scombrotoxin (histamine) forming fish, including Mahi Mahi and Yellowtail tuna, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant deviations include: 1. **Inadequate Critical Limits:** The HACCP plan's critical limits at the "Receiving fresh histamine producing fish in ice or refrigerated from harvest vessel" critical control point were insufficient to control scombrotoxin formation. The critical limit, "Records of vessel performance in relation to method of capture, time to cooling and cool storage on-board vessel," lacked specific parameters for controlling histamine. The FDA provided detailed examples of adequate critical limits for onboard handling and recommended sensory examination of incoming fish. 2. **Inappropriate Corrective Actions:** * **Receiving:** The corrective action for the "Receiving" critical control point (" (b)(4) ") did not ensure adulterated product remained out of commerce. The FDA recommended chilling and holding the affected lot for histamine