(Editor's note: This story has been updated to fix an error. See correction below. 12:15 March 16)
Operators of a dietary supplement manufacturing company have been charged with failing to register a food manufacturing facility and refusing a U.S. Food and Drug Administration inspection.
According to a news release from the U.S. Attorney's Office in Cleveland:
Michael Sanor, age 61, of North Canton, faces one federal count of adulterated food and one count of failure to register a food manufacturing facility.
Shaun Cotterill, age 54, of Monroeville, faces 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.
Cotterill and Sanor operate Genesis Herb, a dietary manufacturer and distributor with locations in both Monroeville and Canton, according to the U.S. Attorney's Office. The pair also operated Genesis Herb Private Membership Association.
FDA inspectors got an inspection warrant for the Genesis Herb's manufacturing facility sites. Access was denied to the areas where the dietary supplements were manufactured and stored at the Monroeville site by Shaun Cotterill in 2016, 2017 and 2018, according to the charges.
“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,” Acting U.S. Attorney Bridget M. Brennan said in a news release.
Cotterill and Sanor are accused of introducing into interstate commerce dietary supplements manufactured, processed, packed, and held in a factory, warehouse, or establishment that did not meet required manufacturing practices, according to the release.
“FDA inspection of these facilities is critical to determining adherence to these regulations and manufacturers who refuse FDA oversight put the public at risk,” Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations Metro Washington Field Office, said in the release.
"Mr. Cotterill and Mr. Sanor, who are both highly respected members of the community, look forward to having their opportunity to address these charges in court and will comment further at the appropriate time,” attorneys Eric Long and Maxwell Hiltner said in a joint statement on behalf of their clients.
The case is being prosecuted by Assistant U.S. Attorney Michael Freeman.
CORRECTION: An earlier version of this story incorrectly stated Sanor and Cotterill have pleaded guilty. They have not done so in court. Incorrect information was supplied Monday by the U.S. Attorney's Office.
The Link LonkMarch 16, 2021 at 11:15PM
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Two Ohio residents facing federal charges in Genesis Herb diet supplement case - Canton Repository
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