with Federal Food, Drug, and Cosmetic Act
WASHINGTON – A federal court today issued an order prohibiting Qualgen LLC, an Oklahoma company, Shaun P. Riney, Qualgen’s Chief Executive Officer, and Jasen Lavoie, Qualgen’s Director of Quality, from manufacturing and distributing drugs that are not in compliance with the Federal Food, Drug and Cosmetic Act (FDCA).
In a civil complaint filed on December 6, the United States alleged that Qualgen, Riney, and Lavoie violated the FDCA at the company’s facilities in Edmond, Oklahoma, by manufacturing and distributing adulterated drugs. As an outsourcing facility registered with the U.S. Food and Drug Administration (FDA), Qualgen makes and distributes sterile drug products, including Bio-Identical Hormone Replacement Therapy pellets (testosterone, estradiol, and testosterone/anastrozole). The United States alleged that the defendants violated the FDCA by, among other things, failing to follow written procedures applicable to the quality control unit, failing to reject drug products that did not meet specifications, and failing to follow appropriate procedures in handling complaints about its drug products. The complaint also alleged that the FDA inspected the company’s facilities five times, in 2015, 2017, 2018, 2021, and 2022, and that many of the violations were repeat violations the FDA had identified in earlier inspections.
The FDCA’s current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which their drugs are manufactured, processed, packed, and held, to ensure that the drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are deemed adulterated under the FDCA. According to the United States’ complaint, the FDA issued Qualgen several warnings, including during meetings with the FDA and in a warning letter to the company in 2016, regarding alleged deficiencies at its facilities.
“Drugs compounded in outsourcing facilities must be manufactured in conformance with applicable regulations,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA and take action against compounding drug manufacturers who fail to abide by laws designed to protect public health.”
“Failure to manufacture drugs in strict compliance with FDA requirements endangers the very people who need and rely on the quality of those medications,” said U.S. Attorney Robert J. Troester for the Western District of Oklahoma. “We gladly partner with the FDA to enforce their regulations in order to ensure public safety is maintained in the pharmaceutical manufacturing and compounding process.”
“While drugs compounded by outsourcing facilities are not subject to pre-market review and approval by the FDA for safety and effectiveness, they must comply with rigorous manufacturing quality assurance requirements,” said Acting Director Jill P. Furman, J.D. of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA’s commitment to ensuring compliance with current good manufacturing practice requirements is a critical protection for patients. We will remain vigilant and hold all manufacturers accountable to best protect the public health.”
Without admitting or denying the allegations in the complaint, the defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and prohibits, among other things, the defendants from manufacturing, compounding, processing, labeling, holding, or distributing adulterated drugs.
Senior Trial Attorney Natalie N. Sanders of the Justice Department’s Consumer Protection Branch and Assistant U.S. Attorney Ronald R. Gallegos for the Western District of Oklahoma handled this matter, with the assistance of Senior Counsel Paige H. Taylor of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.