Operators of dietary supplement company plead guilty to failure to register a food manufacturing facility and refusal of an FDA inspection | USAO-NDOH

The operators of a dietary supplement manufacturing company in Monroeville and Canton, Ohio, pleaded guilty in federal court today to a bill of information charging them with failure to register a food manufacturing facility and refusal of a U.S. Food and Drug Administration (FDA) inspection.  

Shaun Cotterill, age 54, of Monroeville, pleaded guilty to three counts of failure to allow an FDA inspection; one count of introduction of adulterated food and one count of failure to register a food manufacturing facility.

Michael Sanor, age 61, of North Canton, pleaded guilty to one count of introduction of adulterated food and one count of failure to register a food manufacturing facility.

Cotterill and Sanor were members, trustees and operators of Genesis Herb LLC, a dietary manufacturer and distributor located in Monroeville and Canton. 

“Those who purposely subvert the regulatory functions of the FDA by obstructing inspections are potentially endangering the lives of their customers and the general public,” said Acting U.S. Attorney Bridget M. Brennan. “The Department of Justice and our partner agencies will continue to protect the health of the public by ensuring critical regulatory functions, such as this, continue unabated.”

“Federal law requires that dietary supplement manufacturers follow good manufacturing practice to ensure, among other things, that their products contain the labeled ingredients and are not contaminated with harmful or undesirable substances. FDA inspection of these facilities is critical to determining adherence to these regulations and manufacturers who refuse FDA oversight put the public at risk,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office. “We will continue to monitor, investigate and bring to justice dietary supplement firms that ignore these important safety requirements.”

According to court documents, Cotterill and Sanor also operated Genesis Herb Private Membership Association, an organization with trustees located in the Northern District of Ohio that distributed dietary supplements to its members.

On September 22, 2016, December 13, 2017 and April 18, 2018, investigators with the FDA obtained a Warrant for Administrative Inspection for the Genesis Herb Company manufacturing facility site in Monroeville and Canton. On each occasion, investigators attempted to conduct an inspection at the Monroeville facility and were denied access by Shaun Cotterill.

Cotterill initially allowed the inspection of storage areas and out-buildings that contained items such as boxes, packaging materials, shipping labels, invoices and more. However, Cotterill refused to provide access to the areas where the dietary supplements were manufactured and stored on each occasion.

Additionally, Cotterill refused to provide access to manufacturing records required to be kept regulation governing the operation of by Genesis Herb. At each instance, Cotterill was told by an investigator that these refusals would constitute a refusal of inspection. Cotterill claimed he understood, and the inspections were terminated.

According to the Bill of Information and details presented in court proceedings, from September of 2016 through June of 2020, Cotterill and Sanor pleaded guilty to introducing into interstate commerce dietary supplements manufactured, processed, packed, and held in a factory, warehouse, or establishment that did not meet required manufacturing practices. 

In addition, Cotterill and Sanor admitted to failing to renew a registration for Genesis Herb Company as a food manufacturing facility and never registering Genesis Herb Private Membership Association with the FDA as a food facility.

This case was investigated by the Food and Drug Administration, Office of Criminal Investigations.  The case is being prosecuted by Assistant U.S. Attorney Michael Freeman.

 

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