A seafood-processing facility in Honolulu was found to have “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations during a May 17 and 20 inspection by the U.S. Food and Drug Administration.
Click to read the warning letter
The resulting warning letter, dated July 27 and sent from the agency’s San Francisco District Office, informed Tropic Fish Hawaii LLC that its “fresh, refrigerated histamine-forming fish products, including Ahi tuna, mahi mahi, and skipjack tuna” are therefore adulterated, meaning that “they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”
FDA acknowledged the company’s June 13 response to the inspection results, but found that it did not adequately address all the problems observed by inspectors.
The warning letter states that Tropic Fish Hawaii LLC “must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points” to comply with federal law.
FDA noted that the company’s HACCP plan for fresh, refrigerated histamine-forming fish, including tuna, does not list the critical control point of refrigerated storage for controlling the food safety hazard of scombrotoxin (histamine) formation.
An agency investigator observed refrigerated product storage to be at 44 degrees F and the internal temperature of two Ahi tuna in the room to be at 42 degrees F. However, FDA’s letter stated that refrigerated, not frozen, storage or processing of raw product is to be held at a cooler temperature of 40 degrees F or below.
Or, if the fish are stored under ice, the product must be completely and continuously surrounded by ice throughout the storage time, according to the warning letter.
FDA also pointed out that the firm’s HACCP plan for fresh, refrigerated histamine-forming fish such as tuna does not list the food safety hazard of pathogenic bacteria growth for fish intended for raw consumption. The company responded that pathogenic bacteria growth was not considered a potential hazard because it uses potable water in the facility.
“Your response is not adequate and your hazards analysis is incorrect,” the warning letter states. “FDA has identified pathogenic bacteria growth and toxin formation as a food safety hazard in finfish, i.e. tuna, intended for raw consumption and control of this significant hazard must be included in your HACCP plan in the event of time and temperature abuse.”
FDA’s letter also mentioned that the firm was observed monitoring the surface temperature of fish at receiving with an infrared thermometer.
“Your response received on June 13 stated that you have now resumed taking the internal temperature of the fish with a probe thermometer. We will verify the adequacy of your corrective action during our next scheduled inspection,” the letter stated.
Other problems cited at the facility involved current good manufacturing practice requirements. These included not monitoring for the prevention of cross-contamination, insufficient cleaning of food contact surfaces, and inadequate control of employee health conditions.
Specifically, the letter states that an investigator observed unprocessed Ahi tuna intended for raw consumption being stored on a concrete floor and then dragged across the floor onto a pallet by an employee.
The company responded that the employee had received a written warning and was counseled, extra pallets were added for storage, and that plastic platform trucks were ordered to help move products.
FDA called that response “not completely adequate because you have not addressed the steps you have taken to ensure prevention of other employees from engaging in the same practice.”
Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.
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