A seafood processing facility in Colorado is on notice from the Food and Drug Administration for serious violations of the seafood Hazard Analysis and Critical Control point (HAACP) regulation.

Officials from the FDA’s Division IV West Office of Human and Animal Foods inspected the Gypsum, CO, location of Eagle Smoked Salmon Inc. on July 13 and 17. According to an Aug. 23 warning letter recently made public by the FDA, the facility’s vacuum packed, cold smoked salmon; hot smoked salmon, not vacuum packed; and smoked salmon spread may be injurious to health as they were prepared, packed or held under insanitary conditions.

The report cited several significant violations in relation to HAACP plan for fish or fishery products:

• The firm failed to conduct, or have conducted, a hazard analysis for each kind of fish and fishery product that they produce, to determine whether there are food safety hazards that are reasonably likely to occur;
• The firm failed to have a HACCP plan that lists monitoring procedures and their frequency for each critical control point, and specifically, the firm’s HACCP plan for “Cold Smoked Salmon Vacuum Packed” lists a monitoring procedure and frequency at the storage CCP that is not adequate to control the growth of Clostridium botulinum;
• The firm did not follow the monitoring procedure of “Thermometer Logger” and frequency of “Throughout the Process” at the smoking critical control point; and
• The firm did not follow the monitoring procedure defined as “Time in Cure,” “Salt content of cure,” and “Weight of fish and salt,” each with frequencies of “Each Batch,” which is intended to control “C. bot, Staph, and Listeria Production (sic) in finished product” as listed in the firm’s “Cold Smoked Vacuum Packed” HACCP plan.

According to the warning letter, the firm previously submitted a proposed HACCP plan in July for the “Smoked Salmon Spread.”

“However, the plan does not include steps to control pathogenic bacteria growth in the raw materials and finished products,” according to the warning letter. “Additionally, the plan does not include control measures to ensure the allergens, egg, milk, and fish are properly declared on all finished product labels.”

The FDA acknowledged the firm’s submitted letter, but noted that, “However, you did not provide any records which demonstrate this observation has been corrected.”

Under FDA regulations, all facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.

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 Hazards Guide states that, “This guidance is intended to assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products, and help them formulate control strategies. The guidance will help consumers and the public generally to understand commercial seafood safety in terms of hazards and their controls.”

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.

(To sign up for a free subscription to Food Safety News, click here.)