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FDA warning letters: Foreign, U.S. seafood companies on list

Seafood companies in Alabama and Indonesia are on   warning from the Food and Drug Administration for serious violations of U.S. law, specifically the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Such violations generally result in companies’ food being determined to be adulterated and therefore possibly injurious to health. The FDA allows companies 15 working days to respond to warning letters.

Companies that do not respond within the 15-day period, or those who fail to adequately respond, are subject to other enforcement efforts, including food recalls, seizure of products, forced closure or other activities.

There is frequently a lag time of days to weeks before FDA makes warning letters available to the public on its website. The agency posted the following letters on its website in recent days.

Timothy Neilsen Seafood, Coden, AL
In a Dec. 19 warning letter to Timothy O. Neilsen, owner of Timothy Neilsen Seafood in Coden, Ala., the FDA described violations inspectors found in ready-to-eat crab on Nov. 2, 3, 6 and 7 of last year.

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement an HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated,” according to the warning letter.

“Accordingly, your refrigerated, ready-to-eat crab meat is adulterated, in that is has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.”

The Alabama seafood company failed to conduct, or have conducted, hazard analysis for each type of its fish or fishery products. Without that analysis, FDA warned, a company cannot “determine whether there are food safety hazards that are reasonably likely to occur…”

“However, your firm does not have a HACCP plan for refrigerated, ready-to-eat crab meat to control the food safety hazards of environmental chemical contaminants, pathogenic bacterial growth due to temperature abuse, pathogenic bacterial survival through cooking or pasteurizing, allergens, and metal inclusion,” FDA’s warning letter said.

The federal agency cited other problems at the Timothy Neilsen Seafood company in the letter. The company’s records do not contain documentation of sanitation controls, including hand washing, hand sanitizing and toilet facilities; protection of food, food packaging material and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants; proper labeling, storage and use of toxic compounds; and control of employee health conditions that could result in the microbiological contamination of food, food packaging materials and food contact surfaces.

PT. Galaxy Nusa Dua, Jawa Barat, Indonesia
In a Dec. 29 warning letter to Director Abdul Rahman at the PT. Galaxy Nusa Dua JL seafood company in Indonesia, the FDA described “significant deviations” found during an Oct. 12-15, 2017, inspection at an importer’s facility in California.

Inspectors discovered that Gourmet Fusion Foods Inc. in Culver City, Calif., was importing fish from the Indonesian company, but that the foreign company’s HACCP plan for frozen, vacuum-packed tuna was not in compliance with U.S. law. The FDA warning detailed a number of specific problems with the plan, including these:

The firm’s HACCP plan for frozen tuna does not list the critical control point or multiple critical control points for unrefrigerated processing to control scombrotoxin (histamine) formation. FDA recommends 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. Because the frozen tuna product is consumed as sushi and is considered a raw, ready-to-eat product, the company should also identify the food safety hazard of pathogen growth as a reasonably likely hazard.

The company’s HACCP plan incorrectly lists critical control points for temperature that are not adequate to prevent Clostridium botulinum toxin formation and scombrotoxin (histamine) formation, according to the warning letter.

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