The seaside area of Muara Baru is the largest fishing port in Indonesia. Located in North Jakarta, seafood processor P.T. Indomaguro Tunas Unggul says it has “sophisticated technology to produce natural frozen sashimi grade tuna.”

P.T. promises that its tuna-filled ships sailing across the Pacific Ocean to the United States use hygienic processes and sophisticated technology.  The European Commission and the U.S. have both “acknowledged” P.T.’s Hazard Analysis and Critical Control Point (HACCP), the company says.

But when investigators from the U.S. Food and Drug Administration (FDA) left the North Jakarta tuna processor last October, they were concerned not only about shortcomings in P.T.’s HACCP plan, but also “the open drainage canal and debris surrounding your facility.”

FDA visited the North Jakarta last Oct. 18 and 19, and found enough deviations from seafood HACCP regulations to cause it to declare P.T. tuna adulterated.

In a March 18 warning letter to the company, FDA acknowledged that P.T. provided it with a new HACCP plan last Nov. 5 in response to the agency’s Form 483 inspection report.

The warning letter says the revised HACCP plan still does not list a critical control point for controlling the food safety hazards of histamine and Clostridium botulinum growth and toxin formation.

“There is a potential for histamine development, as well as Clostridium botulinum growth and toxin formation as a result of time and temperature abuse during this extended refrigerated hold period, ” FDA wrote.  “We recommend that the fish be held at or below 38°F to control toxin formation.”

FDA said P.T is “not following the monitoring procedures associated with the use of a continuous method of monitoring cooler storage.”

“These monitoring procedures listed in your plan indicate that your firm is using a continuous thermometer and data logger for continuously monitoring and recording cooler storage; however, our inspection revealed that your firm is visually monitoring cooler temperatures every hour,” the letter adds. “In addition, your November 5th response included cooler monitoring records showing hourly temperature checks.”

FDA also points out that putting something in a plan does not make it so.

“There is no clear explanation for the meaning of ‘check histamine’; however, even when conducting further histamine testing, your firm has not provided a statistically sound strategy for sampling to ensure that the sampling of the fish is sufficiently representative to detect elevated histamine levels,” it says.

As for that open drainage canal running through the seafood processor and the debris surrounding it, FDA says it want the 12-year-old tuna company to build above-ground wastewater pipes designed “to continually remove sewage and wastewater as soon as possible.”

FDA says P.T. must correct the violations or face potential loss of the ability to ship tuna into the U.S.