Irish seafood processor issued FDA warning for violating US food safety laws

A seafood processor based out of Clare, Ireland, was issued a warning letter by the Food and Drug Administration for what the agency called significant violations of U.S. food safety laws.

According to the FDA’s letter, Burren Smokehouse Ltd.’s hot- and cold-smoked salmon, trout, and mackerel products were all found to be adulterated, having been prepared, packed, or stored under conditions that rendered them potentially hazardous to human health. Agency inspectors found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) as it applies to the company’s refrigerated, vacuum-packaged hot and cold smoked fish products and flow charts. An SOP was identified for cleaning the vacuum packaging machine, the FDA noted.

The letter, which was dated 30 July, 2019, was sent to Burren Smokehouse Ltd.’s managing director Birgitta Hedin Curin. The FDA said it received email responses from Burren Smokehouse on 21 March, 2 April, and 29 April regarding the deviations observed by inspectors in March, with the agency evaluating the company’s corrective response to each of the violations, which – according to Food Safety News – include: 

  • The firm’s HACCP plans provided with its responses does not list one or more critical control points to control the food safety hazard of pathogen growth and toxin formation; “which is not included as a critical control point needs to be listed as an actual critical control point to control the hazard of C. botulinum growth and toxin formation in the vacuum-packaged finished product and pathogen growth and toxin formation during salting”;
  • The firm must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point;
  • Upon further review of the firm’s revised HACCP plans, FDA recommends the firm update its critical limits at refrigerated storage and in-process handling to ensure the products are held at or below 4.4 degrees Celsius (40 degrees Fahrenheit) or less, rather than 5 degrees Celsius;
  • The firm’s critical limits need to address finished product labeling;
  • FDA recommends a critical control point for finished product labeling with a critical limit that lists all finished product labeling must accurately declare all major food allergens that are included in the product formulation; and
  • The firm’s HACCP plan for its hot smoked farmed trout does not identify the hazard allergens.  

“Your response should include documentation and information that would assist us in evaluating your corrections, such as documentation reflecting the changes you made, such as a copy of your revised HACCP plans, five consecutive days of completed monitoring records (i.e., complete sets of monitoring records for the production of five production date codes of products) to demonstrate implementation of the plans, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the seafood HACCP regulation,” the FDA wrote in its letter.

 “If you do not respond or if we find your response inadequate, we may take further action,” the FDA added.


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