A seafood processor in Indonesia is on notice from the Food and Drug Administration for serious violations of the seafood Hazard Analysis and Critical Control Point (HAACP) regulation.
According to the Dec. 29 warning letter recently made public by the FDA, the processor’s frozen vacuum packaged tuna were rendered injurious to health as they were prepared, packed or held under insanitary conditions.
Officials from the FDA inspected the Culver City, CA, location of Gourmet Fusion Foods Inc., an importer of the firm’s seafood products, from Oct. 12 through 25 of 2017.
“During the inspection of the importer, we collected a copy of your HACCP plan entitled ‘Frozen Tuna’ dated April 20, 2017,” according to the warning letter.
The report cited several significant violations in relation to HAACP plan for fish or fishery products:
- The firm’s HACCP plan for their Frozen Tuna does not list the critical control point or multiple critical control points for unrefrigerated processing for controlling the food safety hazard of scombrotoxin (histamine) formation;
- The FDA recommended that the firm include a critical control point or individual critical control points to monitor the cumulative time and temperature of exposure from when the first fish in the lot is received until the last finished fish from the lot is placed in the freezer;
- The firm’s critical control point limits are not adequate to control Clostridium botulinum toxin formation;
- The firm’s critical limits are not adequate to control scombrotoxin (histamine) formation that is reasonably likely to occur during transit from the supplier to the processing plant;
Additionally, the firm’s corrective action plans for their tuna at the following critical control points were not appropriate to control scombrotoxin (histamine) formation and Clostridium botulinum toxin formation. The corrective action plans do not ensure that no adulterated product enters commerce.
The FDA recommended “segregating and destroying any label stock that does not contain the proper statement and determining and correcting the cause of improper labels” as well as segregating and relabeling any improperly labeled product
The FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance, the Hazards Guide, “provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products.”
The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations. FDA has not yet posted a closeout letter on the case.