SAN FRANCISO – Sterigenics International LLC and its parent, Sterigenics U.S., LLC, agreed to pay $450,000 to settle allegations by the U.S. Department of Justice that the companies failed to keep and maintain adequate records pertaining to controlled substances, announced United States Attorney Melinda Haag and U.S. Drug Enforcement Administration Acting Special Agent in Charge Bruce Balzano.
Sterigenics is registered as a manufacturer with the DEA, with current authorization to handle certain substances under the Controlled Substances Act, 21 U.S.C. § 801. Specifically, Sterigenics has current authorization to handle certain Schedules II, III, III, and IV controlled substances. In addition, Sterigenics has been approved for a manufacturing license at its Hayward, Calif., location since 2007 and provides contract sterilization for the pharmaceutical, medical device, and food industries at its Hayward plant. In the agreement signed by the Justice Department last Friday, Sterigenics acknowledged it had an obligation to “keep and maintain” records related to its receipt, manufacturing, and distribution of controlled substances in connection with its operations at its Hayward plant. According to the settlement agreement, the Drug Enforcement Administration conducted an investigation and concluded that between April 4, 2011, and April 4, 2013, Sterigenics failed to comply with the Controlled Substances Act in at least 156 instances. The alleged violations included a wide range of documentary deficiencies including the failure to record or maintain adequate inventory records and the failure to record or maintain records of the receipt, storage, or shipment of controlled substances. According to the terms of the agreement, Sterigenics will pay the government $450,000 to resolve all civil and administrative claims related to the alleged recordkeeping violations identified in the investigation.
Assistant U.S. Attorney Jonathan U. Lee handled this matter with the assistance of paralegals Wilson Wong and Cheryl Wagerman.