Holmes County Company Fined More Than $165,000 for Refusing to Allow FDA Investigators to Inspect Its Facilities
Department of Justice
U.S. Attorney’s Office
Northern District of Ohio
FOR IMMEDIATE RELEASE
Wednesday, September 18, 2019
A Holmes County company that advertised it manufactured tinctures, salves and herbal formulas was fined more than $165,000 for refusing to allow FDA investigators to inspect its facilities.
Precision Herbs LLC was ordered to pay a fine of $166,965 –- which represented the profits of their business after they refused FDA Inspection. Original Design Wellness was fined $2,000. Company officials Sharon Overman and Eric Pierce were both sentenced to six months of probation and ordered to pay a $2,000 fine.
All parties previously pleaded guilty to one count of refusal of inspection and one count of introduction of adulterated drugs and devices.
According to the criminal information filed in U.S. District Court:
Precision Herbs advertised it manufactured “alcohol-based tinctures, salves and vegetable-based encapsulations of unique herbal formulas” that “address(ed) individual wellness needs and improved daily living.”
Original Design Wellness Center was associated with Precision Herbs and distributed Precision Herbs’ products. Overman, 75, and Pierce, 50, owned both companies.
The FDA obtained a warrant on January 15, 2016 to inspect Precision Herbs’ facilities in Killbuck and Millersburg, Ohio. Original Design Wellness Center was operated out of the Millersburg facility.
FDA investigators, accompanied by U.S. Marshals, attempted to conduct an inspection of both locations on January 21, 2016. Overman and Pierce refused the inspection of the Millersburg facility. Pierce initially allowed the inspection of the Killbuck facility until a third party arrived and disrupted it. Pierce allowed the disruption and the inspection was terminated.
The companies, Overman and Pierce continued to sell products that were manufactured from a location that refused to permit inspection by the FDA. This took place between January 21, 2016 and May 24, 2017.
“Today’s announcement demonstrates that those who purposely subvert the regulatory functions of the FDA by obstructing inspections will be held accountable for their actions,” said Special Agent in Charge Mark S. McCormack, FDA Office of Criminal Investigations, Metro Washington Field Office. “We value the efforts of the Department of Justice for vigorously pursuing the prosecution of this matter.”
This case was investigated by the FDA and prosecuted by Assistant U.S. Attorney Alejandro Abreu.
USAO - Ohio, Northern
Mike Tobin 216-622-3651 firstname.lastname@example.org