Seafood company closed due to alleged food safety problems
The US Department of Justice (DOJ) said a consent decree of permanent injunction had been entered against Mill Stream Corporation (doing business as Sullivan Harbor Farm) and its owner, Ira Joel Frantzman to prevent product distribution.
The complaint, filed in the District Court of Maine, alleges that, for more than a decade, FDA warned the defendants about HACCP and cGMP violations at the facility.
It also alleges that FDA communicated these warnings through several measures but continued to observe violations at the site.
However, the original consent decree was filed in October last year with the final paperwork submitted on Friday in Bangor, Maine Federal Court.
The firm told FoodQualityNews that during that time period the business was sold (in January 2016) to an experienced seafood operator. The new owners have been working with a food safety expert, and the FDA to resolve the compliance issues outlined in the suit.
The new owners expect to be back in production as soon as the FDA approves the new HACCP plans and validation studies, which is expected within a few weeks.
Seafood distribution network
At the time of the compliant, Sullivan Harbor Farm prepared, processed, packed, held and distributed refrigerated, vacuum-packed, ready-to-eat, cold and hot smoked fish products, such as smoked salmon, trout and char, for distribution to cities including Boston, Massachusetts and Washington DC.
The defendants agreed to settle the case and be bound by the consent decree that requires them to cease all manufacturing operations.
For them to resume distributing products, FDA must determine that manufacturing practices comply with the federal Food, Drug and Cosmetic Act (FDCA).
The complaint alleged the defendants’ seafood products are adulterated as they have been prepared, packed, or held under unsanitary conditions where they may have become contaminated with filth or rendered injurious to health.
FDA inspections
An FDA inspection in March and April 2015 identified ‘significant, recurring’ violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations and current Good Manufacturing Practices (cGMP) requirements, according to the compliant.
The HACCP violations included inadequate plans to control risks of Clostridium botulinum (C. bot), which produces a neurotoxin that can cause botulism.
FDA investigators observed rodent excrement ‘too numerous to count’ in the facility where smoker trays are cleaned, apparent black mold and water staining on the doorframe of the walk-in freezer where fish is stored, and water splashing from the processing floor onto a cutting board and into bins where fish is stored, according to the compliant.
“The failure to plan for and control the presence of bacteria and neurotoxins commonly found in seafood-processing facilities can pose a significant risk to the public health,” said Benjamin Mizer, principal deputy assistant attorney general, head of the Justice Department’s Civil Division
FDA’s testing of samples collected from the defendants’ facility during a December 2011 inspection revealed Listeria monocytogenes (L. mono) in the facility’s environment and on a fish-skinning machine.
The agency issued an Administrative Detention Order to the defendants and they had the affected products destroyed and recalled.
In response to the December 2011 inspection, the defendants promised to make certain corrections, including conducting L. mono environmental testing. However, FDA’s inspection in March/April 2015 revealed they had discontinued such testing.
