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.

Explora was acquired by CRL in April 2022 for approximately $295 million in cash, as part of CRL’s expansion into contract vivarium research services, but public SEC filings from CRL do not delve into the specifics of the pre-acquisition violations or any internal investigations.

Charles River Laboratories, Inc. (CRL) operates as a contract research organization (CRO) in California, providing products and services to support drug discovery, early-stage development, and manufacturing for pharmaceutical and biotechnology clients.

Their operations in the state include rodent breeding facilities in Hollister, as well as multiple Charles River Accelerator and Development Lab (CRADL) sites offering turnkey rentable vivarium spaces and in vivo research support services in regions like the San Francisco Bay Area and Thousand Oaks. This includes contract vivarium management, preclinical testing, and related infrastructure for biotech companies.

A vivarium is an enclosed area or container designed for keeping and raising live animals or plants under conditions that simulate their natural environment, typically for observation, research, or as pets. It can range from simple glass terrariums for small reptiles or insects to larger laboratory facilities for scientific studies. In research contexts, like those involving biotech or pharmaceutical companies, vivariums often house animal models (such as rodents) for preclinical testing and must meet strict standards for humidity, temperature, lighting, and biosecurity.

U.S attorneys alleged that Explora nevertheless engaged in those activities at its South San Francisco and San Diego facilities without the appropriate registration. Based on its investigation, they claimed 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 alleged that CRL has successor liability for Explora’s violations of the CSA, but does not allege that CRL itself violated the CSA.

“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.  

There is no indication that litigation was filed in court regarding this case. The matter was resolved through a civil settlement agreement with the U.S. Department of Justice to address the allegations of Controlled Substances Act violations, without any formal complaint or lawsuit being initiated in a judicial proceeding.

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