Genco Pharmaceuticals Services to Pay Civil Penalty of $2,000,000
Gregory J. Haanstad, United States Attorney for the Eastern District of Wisconsin, announced yesterday that the United States has settled civil penalty claims against Genco for alleged violations of the Controlled Substances Act (CSA) and its implementing regulations. Under the settlement agreement, Genco will pay a civil penalty to the United States of $2,000,000.
Genco is a company that specializes in the handling, processing and destruction of pharmaceutical returns, including controlled substances, from pharmaceutical manufacturing and retail companies throughout the United States. Genco’s return processing facility for controlled substances is located at 6101 North 64th Street in Milwaukee, Wisconsin. Because Genco processes and handles controlled substances, it is required to operate in accordance with the CSA.
As reflected in a written Settlement Agreement, the United States contends that it has certain civil penalty claims arising under the CSA against Genco for the following conduct commencing January 1, 2012:
(1) failing to make, keep and furnish accurate records of all stocks of controlled substances on hand and each controlled substance received, sold, delivered or otherwise disposed of;
(2) failing to make, keep and furnish complete and accurate DEA order forms (Form 222) documenting all receipts of schedule II controlled substances;
(3) failing to furnish complete and accurate reports to DEA’s Automation of Reports and Consolidated Orders System Unit of data on each acquisition to inventory and each reduction from inventory of Schedule II controlled substances, narcotic controlled substances listed in Schedule III, and drugs listed in 21 C.F.R. § 1304.33(d); and
(4) failing to notify the Field Division Office of the Drug Enforcement Administration, in writing using DEA Form 106, of thefts and significant losses of Schedule III-V controlled substances within one business day of the discovery of the theft or loss.
The CSA provides for a civil penalty of up to $10,000 for each violation of the Act. This matter was investigated by Diversion Investigators with the Milwaukee Field Office of the United States Drug Enforcement Administration. Genco cooperated in the DEA’s investigation and has taken significant steps to prevent future violations of the CSA.
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For Additional Information Contact:
Public Information Officer Dean Puschnig 414-297-1700