December 14, 2023: “The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree.
According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturing quality requirements within the U.S. marketplace.
“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 the FDA’s Center for Drug Evaluation and Research.
“The 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 manufactures and distributes over-the-counter drugs, as well as human and animal prescription drugs such as topical corticosteroids and inhalant anesthetics. Pharmasol is under contract with multiple pharmaceutical companies.
According to the complaint, the defendants violated federal law under the FD&C Act by introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements; therefore, these drugs are adulterated.
The most recent inspection of the company’s facilities in 2022 found the majority of the inspectional observations repeated those found in past FDA inspections and detailed in a 2019 warning letter. Violations mentioned in the complaint include failure to:
- fully investigate errors and ensure that the responsibilities and procedures applicable to the quality control unit are in writing and fully followed, including reporting drug defects to customers;
- follow written procedures that describe the handling of written and oral complaints regarding a drug product; and,
- adequately clean and maintain equipment.
In the 2019 warning letter, the agency cited customer complaints of product leakage out of the container and the company’s failure to investigate. Despite repeated warnings, the company and Badia continued to violate the law.
The consent decree prohibits Pharmasol and Badia 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 to ensure that Pharmasol operates in compliance with the FD&C Act, the FDA’s regulations, and the decree, and defendants receive written notice from the FDA that they appear to be in compliance with these requirements.”