U.S. Court Orders Pharmasol Corporation to Halt Drug Distribution Over FD&C Act Violations

LegalImage by Mike Braun

The FDA announced that the U.S. District Court for the District of Massachusetts recently issued a consent decree of permanent injunction against the Pharmasol Corporation, a Massachusetts-based company, and its President Marc L. Badia. The court order mandates that the company cease the distribution of drugs until it complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other stipulations listed in the consent decree.

The complaint, filed jointly with the consent decree by the U.S. Department of Justice, alleges that Pharmasol and Badia unlawfully distributed adulterated drugs. These drugs reportedly failed to meet manufacturing quality requirements, contravening established laws for the U.S. marketplace.

Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, stated, “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.”

Pharmasol’s portfolio includes over-the-counter drugs and human and animal prescription drugs such as topical corticosteroids and inhalant anesthetics. The company works under contract with various pharmaceutical companies.

The complaint further details that the defendants violated the FD&C Act by introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements. Such non-compliant drugs are considered adulterated.

An inspection of the company’s facilities in 2022 revealed repeated violations that were previously highlighted during past FDA inspections and detailed in a 2019 warning letter. These violations include failure to fully investigate errors, follow written procedures for handling complaints about a drug product, and adequately clean and maintain equipment. Despite repeated warnings, the company and Badia continued to violate the law, leading to the current court order.

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Under the consent decree, Pharmasol and Badia are prohibited from any drug manufacturing, preparation, processing, packing, receiving, labeling, holding, and distribution at their facilities. This prohibition remains in place unless and until the defendants meet certain requirements to ensure Pharmasol operates in compliance with the FD&C Act, FDA regulations, and the decree. Only after receiving written notice from the FDA confirming their apparent compliance can Pharmasol and Badia resume operations.

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