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Charles River Laboratories, Controlled Substances Act Violations, California 2023

San Francisco, CA – 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.”

Defendant: Charles River Laboratories, Inc. (CRL)

Criminal Charges: Unlawful manufacturing and distribution of controlled substances in violation of the Controlled Substances Act (CSA)

City and State: San Francisco, CA

Exact Date: Not specified

Sentence or Outcome: CRL agreed to pay $1,000,000 and entered into a separate agreement with the DEA to ensure compliance with the CSA over the next three years

Dollar Amount: $1,000,000

Defendant Name: Charles River Laboratories, Inc. (CRL)

Criminal Charges: Unlawful manufacturing and distribution of controlled substances in violation of the Controlled Substances Act (CSA)

City and State: San Francisco, CA

Exact Date: Not specified

Sentence or Outcome: CRL agreed to pay $1,000,000 and entered into a separate agreement with the DEA to ensure compliance with the CSA over the next three years

Dollar Amount: $1,000,000

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