District Court Enjoins Massachusetts Pharmaceutical Manufacturer from Making and Selling Adulterated Drugs

A federal court yesterday enjoined a Massachusetts company from manufacturing and distributing adulterated drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA).

In a complaint filed on Nov. 17, the United States alleged that Pharmasol Corporation and its president, Marc L. Badia, violated the FDCA at the company’s facility in South Easton, Massachusetts, by manufacturing and distributing adulterated drugs. Pharmasol manufactured and processed prescription and over-the-counter drugs, including Lexette, which is used to treat itching, redness and swelling of skin, and Dexamethasone, which is used to relieve arthritis inflammation. The United States alleged that the company violated the FDCA by failing to notify its customers about defects in its finished products, failing to establish a complaint procedure or corrective action plan despite receiving, within a 12-month period, 533 customer complaints relating to defects in its drug products, and failing to adequately clean and maintain its equipment. According to the complaint, the Food and Drug Administration (FDA) inspected Pharmasol in 2018, 2021 and 2022, and issued the company several warnings, including a warning letter in 2019, regarding its alleged violations. The United States alleged that many of the violations FDA identified in 2022 were repeat violations identified in earlier inspections.

The current good manufacturing practice regulations for drugs mandate that manufacturers control the processes and procedures by which their drugs are manufactured, processed, packed and held, to ensure that the drugs have the identity, strength, quality, purity and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law.

“Drug manufacturers have a responsibility to comply with requirements designed to ensure drug quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Justice Department will continue to work closely with the FDA and take action against manufacturers who fail to meet this responsibility.”

“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 Director Jill Furman of the  in FDA’s Center for Drug Evaluation and Research's Office of Compliance. “The FDA plays an important role in protecting consumers, and we will continue to work with our federal partners to pursue and bring into compliance those who do not prioritize the health and safety of the American public.”

The company and its president agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that they stop manufacturing, processing, labeling, holding or distributing adulterated drugs. Further, the company must recall all adulterated prescription drugs that the company manufactured or distributed on or after Feb. 10, 2022.

The government was represented by Senior Litigation Counsel Christina Parascandola of the Civil Division’s Consumer Protection Branch, with the assistance of Margo Badawy of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the District of Massachusetts also provided assistance.

Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.

The claims resolved by the consent decree announced today are allegations only, and there has been no determination of liability.