Is Pesca Fina, S.A. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

1.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c)(3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your HACCP plan entitled "HACCP plan for Whole, Eviscerated Fish, Histamine Producers" lists critical limits at the "Receiving fresh histamine producing fish in ice or refrigerated from harvest vessel" critical control point which are not adequate to control the food safety hazard of scombrotoxin (histamine) fonnation. Specifically, your critical limit, "Records

o  Fish exposed to air or water temperatures above 83 °F (28.3 °C) were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 6 hours from the time of death;ORo  Fish exposed to air and water temperatures of 83 °F (28.3 °C) or less were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F ( 4.4°C) or less, as soon as possible after harvest, but not longer than 9 hours from the time of death;ORo  Fish that were gilled and gutted before chilling were placed in ice, or in refrigerated seawater, ice slurry, or brine of 40°F (4.4°C) or less, as soon as possible after harvest, but not longer than 12 hours from the time of death;ORo  Fish that were harvested under conditions that expose

Potential Health Risks

In accordance with 21 CFR 123 .6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your fresh wild caught whole, eviscerated scombrotoxin (histamine) forming fish, including your Mahi Mahi (i.e., Dorado) and Yellowtail tuna (Thunnus Albacares) are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and FD A's 4th Edition of the Fish and Fish

Regulatory Context

On April 4, 2017, a representative of the UnHed States Food and Drug Administration (FDA) conducted an inspection of a fish and fishery products importer located in the United States,(b)(4)located in(b)(4), to assess that importer's compliance with the United States Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), refened to as the seafood HACCP regulation. That importer was found to be importing fresh wild caught whole, eviscerated yellowtail tuna (Thunnus Albacares) from your processing facility. During the inspection of that impo11er, we collected a copy of your firm's HACCP plan for fresh wild caught whole, eviscerated yellowtail tuna (Thunnus Albacares). Our evaluation of that HACCP plan (copy att

2.    Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans for your "HACCP plan for Whole, Eviscerated Fish, Histamine Producers" at the following critical control points to control scombrotoxin fonnation are not appropriate:

a.  At the "Receiving fresh histamine producing fish in ice or refrigerated from harvest vessel" critical control point, your corrective action indicates you will "(b)(4)." However, the corrective action does not ensure that adulterated product remains out of commerce. In the absence of harvest vessel records or when one of the harvester-related critical limits has not been met, or when the internal temperature critical limit at receiving has not been met FDA recommends that firms: