CALIFORNIA – The U.S. Department of Justice (DOJ) announced January 5 that a California-based research company has agreed to pay $1,000,000 to resolve allegations of unlawful activity.
It is accused of manufacturing and distributing controlled substances between 2019 and 2022, in violation of the Controlled Substances Act (CSA).
The company, Charles River Laboratories, Inc. (CRL), is the successor by merger to Explora Biolabs Holdings, Inc.
CRL also entered into a separate three-year compliance agreement with the U.S. Drug Enforcement Administration.
Researcher registrations don’t permit drug production or distribution
Explora, a contract vivarium research provider, was previously registered with the DEA for facilities in South San Francisco and San Diego.
Both facilities held Researcher registrations, which generally do not authorize the manufacturing or distribution of controlled substances.
The United States alleges Explora engaged in these activities at its South San Francisco and San Diego facilities without proper registration.
The United States contends that Explora unlawfully manufactured and distributed controlled substances in at least 178 instances, violating CSA provisions regulating these activities and breaching multiple recordkeeping requirements.
The United States alleges that CRL is liable as Explora’s successor but does not claim that CRL itself violated the CSA.
Research not an excuse to violate the law
DEA Special Agent in Charge Bob P. Beris said research is not an excuse to violate the law.
“We expect companies utilizing a DEA researcher registration to adhere to the parameters of its permitted practices,” Beris said.
The claims resolved by the settlement are allegations only; there has been no determination of liability.
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