12-14-2023 6:02pm

Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs

Anita Johnson-Brown Editor

The U.S. District Court for the District of Massachusetts has issued a permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and its 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. The court ruled that the company unlawfully distributed adulterated drugs, which means they do not comply with manufacturing quality requirements in the U.S. marketplace.

According to the complaint filed by the U.S. Department of Justice, Pharmasol and Badia violated federal law under the FD&C Act by introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements, making these drugs adulterated. Pharmasol manufactures and distributes over-the-counter drugs, as well as human and animal prescription drugs such as topical corticosteroids and inhalant anesthetics, under contract with multiple pharmaceutical companies.

The FDA's Center for Drug Evaluation and Research director, Jill Furman, said that when drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk. In this case, the defendants' company distributed adulterated, poor-quality drugs without regard for patients and consumers. The FDA plays an important role in protecting consumers, and they will continue to work with their law enforcement partners to pursue and bring into compliance those who do not prioritize the health and safety of the American public.

The most recent inspection of the company's facilities in 2022 found that most 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, 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 comply with these requirements.

By Anita Johnson-Brown|The Los Angeles News