On Sept. 30, the Food and Drug Administration sent a warning letter to Shin Ho Sing Ocean Enterprises Co. Ltd. in Kaohsiung City, Taiwan, to inform the company that its HACCP plan for frozen, cooked saury did not meet federal requirements.
The warning letter explained that FDA had acquired a copy of the firm’s HACCP plan during a June 13 inspection of Hadson (Toko) Trading Co. Inc., an importer of fish and fishery products in Maspeth, NY, that imports saury, a type of fish, from the Taiwan processing facility.
The following “significant deviations” were found, according to FDA:
The HACCP plan does not list critical control points for unrefrigerated processing to control the food safety hazard of scombrotoxin, or histamine, formation.
According to the company’s standard operating procedure document, multiple processing steps are conducted prior to the “cooking” critical control point where the fish are potentially exposed to temperatures between 40 and 70 degrees F, the warning letter stated.
FDA recommends limiting the cumulative exposure time to 12 hours total for all unrefrigerated processing steps when ambient temperatures do not exceed 70 degrees F to control scombrotoxin formation. When exposure temperatures exceed 70 degrees F, the cumulative time should be limited to three hours, the agency wrote.
Also, the “cooking” critical control point described in the HACCP plan is inadequate as the sole critical limit to control the hazard of pathogen survival, FDA added.
“FDA recommends the critical limit include all critical factors (e.g., initial temperature of the product, pouch thickness/size, product size, product formulation, etc.) established by a scientific study. Moreover, your scientific study needs to ensure that these critical factors achieve a minimum 6 log reduction of Listeria monocytogenes, which is the target organism for your product,” according to the warning letter.
Other issues mentioned included the company’s corrective action plan for histamine testing, sensory evaluation for decomposition, and disposition of product such as recooking it, diverting it to a non-food use, or destroying it.
Since the company may use oxygen-impermeable packaging and distributes the product frozen, FDA suggested freezing the product immediately after cooking it in packaging with labeling containing this statement: “Important, Keep frozen until used, thaw under refrigeration immediately before use.”
“In addition to identifying the food safety hazard of scombrotoxin (histamine) formation at an unrefrigerated processing critical control point, your firm may also need to identify the hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus, if your firm significantly handles the saury after the roasting step,” the warning letter concluded.
Pistachio warning letter
FDA’s San Francisco District Office sent a warning letter dated Oct. 7 to The Wonderful Company in Los Angeles noting that Salmonella Senftenberg and Salmonella Liverpool had been found in some raw, in-shell pistachios collected at its Paramount Farms in Lost Hills, CA, during an inspection conducted from March 8 through April 7.
FDA and the U.S. Centers for Disease Control and Prevention have linked The Wonderful Company’s pistachios to a multistate Salmonella outbreak this past spring which sickened at least 11 people in nine states and hospitalized two of them.
On March 9, the company recalled various flavors and sizes of in-shell and shelled pistachios sold under the brand names Wonderful, Paramount Farms and Trader Joe’s.
FDA gave The Wonderful Company 15 working days from the date of receipt of the warning letter to fully document any manufacturing process changes it plans to make, or has made, to prevent future Salmonella problems.
Food Safety News posted a separate story Oct. 14 on FDA’s warning letter to The Wonderful Company.
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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