Consent Decree Entered Against Pharmasol

FDA announced on Dec. 14, 2023 that the US District Court for the District of Massachusetts has entered a consent decree of permanent injunction against Pharmasol Corporation and its president, Marc L. Badia, for distributing adulterated drugs. The injunction orders the company to stop distributing products until it complies with requirements under the Federal Food, Drug, and Cosmetic (FD&C) Act. The complaint states the company violated the FD&C Act by distributing drugs through interstate commerce, which do not comply with current good manufacturing practices.

A 2022 inspection of the company’s facilities found repeated violations from a previous 2019 warning letter that include failures to investigate errors, follow written procedures, and adequately clean and maintain equipment. The 2019 warning letter stated customers complained of product leakage, which was not investigated properly by the company.

“When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk. In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers,” said Jill Furman, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in an agency press release. “[FDA] plays an important role in protecting consumers, and we will continue to work with our law enforcement partners to pursue and bring into compliance those who do not prioritize the health and safety of the American public.”

Pharmasol, which is under contract with several pharmaceutical companies, manufactures and distributes human and animal prescription drugs and over-the-counter drugs. Products include topical corticosteroids and inhaled anesthetics. Under the consent decree, the company is prohibited from directly or indirectly “manufacturing, preparing, processing, packing, repacking, receiving, labeling, holding and/or distributing any drug, at or from their facilities, unless and until defendants meet certain requirements.”

Source: FDA