Massachusetts-based drugmaker Pharmasol has been ordered to shut down after a series of manufacturing-related shortfalls and failed FDA inspections.
As part of an agreement reached in federal court, Pharmasol and its president, Marc L. Badia, agreed to halt all production and distribution of adulterated drugs and recall all adulterated prescription drugs that the company manufactured or distributed on or after Feb. 10, 2022, according to releases from the FDA and U.S. Department of Justice.
The FDA said the company's medicines "do not comply with manufacturing quality requirements within the U.S. marketplace," so they are considered adulterated.
Pharmasol, which is based in South Easton, Massachusetts, produces and distributes over-the-counter drugs such as Lexette, which is used to treat itching, redness and swelling of skin, and dexamethasone, which is used to relieve arthritis inflammation. The company also makes certain human and animal prescription drugs, according to the FDA.
According to a complaint filed on November 17 by the DOJ, the company failed to notify customers about defects in its finished products and failed to establish a complaint procedure or corrective action plan despite having received 533 customer complaints over a 12-month period.
The company was also dinged for not adequately cleaning and maintaining its manufacturing equipment.
“When drug manufacturers violate the law and disregard safety standards, they put consumers at significant risk,” Jill Furman, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the release. “In this case, the defendant’s company distributed adulterated, poor-quality drugs without regard for patients and consumers.”
The regulatory agency said the company’s facility underwent inspections in 2018, 2021 and 2022 and was issued several warnings, including a 2019 warning letter. In its complaint, the U.S. alleged many of the violations the FDA found in 2022 were repeat violations identified in earlier inspections.
“Drug manufacturers have a responsibility to comply with requirements designed to ensure drug quality and safety,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, said in the release. “The Justice Department will continue to work closely with the FDA and take action against manufacturers who fail to meet this responsibility.”