Saturday, July 1, 2017

Acting Manhattan U.S. Attorney Sues To Shut Down Mamaroneck Fish Smokehouse After Findings Of Listeria

Court Approves Consent Decree Requiring Shut Down of Operations Until Violations Are Redressed

  Joon H. Kim, the Acting United States Attorney for the Southern District of New York, and Melinda K. Plaisier, Associate Commissioner for Regulatory Affairs of the Food and Drug Administration (“FDA”), announced today the filing of a Complaint and the entry of a Consent Decree against defendants SMOKEHOUSE OF NEW YORK, LLC (“Smokehouse”), its director of operations, BRETT H. PORTIER (“Portier”), and its president and owner, PANAGIOTA SOUBLIS (“Soublis”), for violations of the Food, Drug, and Cosmetic Act and related food-safety regulations at Smokehouse’s Mamaroneck facility, where the defendants prepare and sell fish products and other specialty foods to consumers across the country. 
Acting U.S. Attorney Joon H. Kim stated:  “We will not let businesses put profits over public health.  Smokehouse, Portier, and Soublis have repeatedly put their customers at risk of severe illness.  Our Complaint and today’s Consent Decree hold them accountable and require them to clean up their operations and protect the public.”
FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said:  “The Smokehouse of NY has had several opportunities to come into compliance with the law.  Through the use of modern technology, the FDA was able to establish that the company has resident strains of Listeria in its facility that it has consistently failed to eradicate.  Conditions like these are unacceptable and the FDA took action to protect Americans.” 
According to the Complaint filed Monday in White Plains federal court:
Listeria monocytogenes (“Listeria”) is a bacterium that can be very harmful to human health.  In the general population, it can cause severe flu-like symptoms and, in extreme cases, confusion, loss of balance, and convulsions.  For pregnant women, it can cause miscarriage, stillbirth, premature delivery, or life-threatening infection of the newborn.
The defendants have repeatedly failed to operate their packaged fish business in compliance with food and safety standards set by FDA.  As a result, the FDA has repeatedly found Listeria in their facility.  Although the defendants previously have proposed to undertake corrective measures to address the Listeria problems at their facility, they have failed to fix the problem:  An FDA inspection conducted between March 8 and April 5, 2017, again found Listeria at various locations within the facility, including on direct food-contact surfaces. 
In the Consent Decree entered today, Smokehouse, Portier, and Soublis admit, acknowledge, and accept responsibility for the following:
 The defendants failed to manufacture, package, and store food under conditions and controls necessary to minimize the potential for microorganism growth and contamination. 
  • At each of five inspections conducted by FDA between 2011 and 2015, FDA found Listeria in the facility, including on a food-contact surface and in packaged, ready-to-eat food.
  • Following the 2011-2015 inspections, the defendants took a number of corrective actions that they stated would address the conditions found by investigators.
  • However, during an FDA inspection between March 8 and April 5, 2017, FDA again found Listeria at the facility, including on food-contact surfaces, including a stainless steel table where food is processed and on a plastic tray used interchangeably to hold raw and finished products.
Pursuant to the Consent Decree, Smokehouse, Portier, and Soublis are enjoined from receiving, preparing, processing, packing, labeling, holding, and/or distributing articles of food until they (1) clean and sanitize their facility; (2) implement appropriate pathogen control and other food safety plans; and (3) implement training programs on proper food hygiene and sanitation for all its employees.  Additionally, the Consent Decree requires Smokehouse, Portier, and Soublis to destroy their current stock of processed food and recall certain food previously sold by them.  The defendants are subject to additional actions by the FDA, including mandated future recalls and shut downs, as well as liquidated damages and costs to cover future necessary inspections and other monitoring actions, if they violate the provisions of the Consent Decree.
Mr. Kim thanked the FDA for its work leading to the Complaint.

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