In a significant development, the U.S. District Court for the District of Massachusetts has issued a consent decree of permanent injunction against Pharmasol Corporation, a Massachusetts-based pharmaceutical company, and its President, Marc L. Badia.
The court order mandates Pharmasol to cease the distribution of drugs until the company rectifies its compliance with the Federal Food, Drug, and Cosmetic (FD&C) Act and other stipulated requirements.
Allegations and Legal Actions
The consent decree follows a complaint filed by the U.S. Department of Justice, accusing Pharmasol and Badia of unlawfully distributing adulterated drugs that do not meet the manufacturing quality standards within the U.S. marketplace. This violation of federal law under the FD&C Act involves introducing drugs into interstate commerce that fail to comply with current good manufacturing practice requirements.
Jill Furman, Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, expressed concern about the significant risks posed by companies that violate the law and disregard safety standards. She emphasized the FDA’s commitment to protecting consumers and vowed to collaborate with law enforcement partners to ensure compliance with health and safety regulations.
Pharmasol Corporation is a Massachusetts-based pharmaceutical company engaged in the manufacturing and distribution of over-the-counter drugs, as well as human and animal prescription drugs. The company produces a range of products, including topical corticosteroids and inhalant anesthetics, under contract with multiple pharmaceutical companies.
Repeat Offenses and Inspection Findings
The complaint highlighted that the most recent inspection of Pharmasol’s facilities in 2022 revealed repeated observations previously identified in past FDA inspections and detailed in a 2019 warning letter. Violations outlined in the complaint include the company’s failure to investigate errors fully, ensure the adherence to quality control procedures, handle written and oral complaints appropriately, and adequately clean and maintain equipment.
Despite a 2019 warning letter citing customer complaints of product leakage and failure to investigate, Pharmasol and Marc L. Badia continued to violate the law.
Terms of the Consent Decree
The consent decree prohibits Pharmasol and Badia from engaging in various activities related to the manufacturing, processing, packing, labeling, and distribution of drugs unless they meet specific requirements outlined in the FD&C Act, the FDA’s regulations, and the decree itself. The defendants must receive written notice from the FDA confirming compliance with these requirements before resuming operations.
This decisive action by the federal court underscores the government’s commitment to upholding safety and quality standards in the pharmaceutical industry, reinforcing the importance of adherence to regulatory guidelines.