Research Company To Pay $1 Million To Resolve Alleged Violations Of The Controlled Substances Act

SAN FRANCISCO – Charles River Laboratories, Inc. (CRL), successor by merger to Explora Biolabs Holdings, Inc., has agreed to pay $1,000,000 to resolve allegations that Explora engaged in the unlawful manufacturing and distribution of controlled substances between 2019 and 2022 in violation of the Controlled Substances Act (CSA).  CRL also entered into a separate agreement with the U.S. Drug Enforcement Administration (DEA) that contains provisions to ensure the company’s compliance with the CSA over the next three years.

Explora, a provider of contract vivarium research services, was previously registered with the DEA for its facilities in South San Francisco and San Diego.  Both facilities held Researcher registrations, which generally do not authorize the manufacture or distribution of controlled substances.  

The United States alleges that Explora nevertheless engaged in those activities at its South San Francisco and San Diego facilities without the appropriate registration.  Based on its investigation, the United States contends that Explora unlawfully manufactured and distributed controlled substances in at least 178 instances, in violation of provisions of the CSA that closely regulate the manufacture, distribution, dispensation, importation, and exportation of controlled substances, and that Explora also violated multiple recordkeeping requirements of the CSA.

The United States alleges that CRL has successor liability for Explora’s violations of the CSA, but does not allege that CRL itself violated the CSA.

“Entities that exceed the scope of their DEA license can expect heightened investigative scrutiny and severe civil penalties,” said United States Attorney Craig H. Missakian.  “This Office remains committed to working with the DEA to ensure that registrants who do not comply with the Controlled Substances Act are held accountable.”

“We expect companies utilizing a DEA researcher registration to adhere to the parameters of its permitted practices.  This case shows that we will aggressively investigate and hold accountable those who violate the scope of their lawful activities.  Research is not an excuse to violate the law,” said San Francisco Division DEA Special Agent in Charge Bob P. Beris. “Explora’s violations of the Act were on over 150 separate occasions.  The DEA is committed to protecting our communities and ensuring lawful scientific research.”  

“DEA registrants play a critical role in protecting the public and that responsibility starts with strict compliance to the Code of Federal Regulations,” said San Diego Division DEA Special Agent in Charge James Nunnallee. “When or if a company chooses to ignore these obligations, it puts communities at risk and undermines the safeguards designed to keep the public safe.  DEA holds registrants accountable and in turn, expects them to keep the public safe.”

Assistant U.S. Attorney Michael Pyle handled this matter for the government.  The investigation and settlement resulted from a coordinated effort by the U.S. Attorney’s Office for the Northern District of California, and DEA Diversion Investigators in San Francisco and San Diego.  

The claims resolved by the settlement are allegations only; there has been no determination of liability.