To import fish to the United States, a Malaysian company recently shared all of its seafood Hazard Analysis and Critical Control Point (HACCP) plan and supporting documents with the U.S. Food and Drug Administration.
When FDA got through grading those papers, GroPoint Fisheries failed.
The company, based in Labuan, Malaysia, learned that the “failure of a processor of fish or fishery products to have and implement” a plan that is in compliance with U.S. law and regulations “renders the fish or fishery products adulterated.”
“Accordingly, your scombrotoxin-forming fish, such as your tunas and Mahi Mahi, are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” FDA said.
In a July 27 warning letter to GroPoint Fisheries, FDA both identified deviations and issues in the HACCP and supporting documents the company submitted. Some of those concerns include:
– the plan for scombrotoxin-forming fish, such as tunas and Mahi Mahi, does not list a critical control point for overnight-refrigerated storage of fish.
– the plan monitoring procedures for “receiving at the dock” are inadequate to control scrombrotoxin formation.
– the plan’s “plant receiving and wash fish” critical control point relies on visual inspection of ice surrounding fish, which is inadequate.
– the plan’s “plant receiving” and “wash fish” should be considered independently and not combined.
– the plan shows use of chlorinated water to wash fish to control pathogens, but does not provide for controlling chlorine concentrations.
In asking for a response to its concerns within 30 working days, FDA also requested “at least five (5) product days worth of monitoring records to demonstrate you have implemented the revised plan…”
FDA also reminded the company that it could detain food products without physical examination upon entry to the U.S. through its Import Alerts if it finds a foreign firm is not in compliance with seafood HACCP requirements.