SETTLES CASE BY AGREEING TO INJUNCTION
A Massachusetts company, Phamasol Corporation, and its president, M.L.B., have agreed to settle a federal lawsuit which alleged that the company made and distributed adulterated drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA).
The government alleged that those parties had failed to notify customers about purported product-related defects, failed to implement a complaint procedure or to take corrective action even after receiving some 533 customer complaints about its drugs. In addition, the company allegedly failed to “adequately clean and maintain its equipment."
Despite several inspections and warning letters, the company is said to have repeatedly skirted its legal obligations, leading to the filing of a federal lawsuit filed in mid-November. In addition to consenting to a permanent injunction and agreeing to comply with the mandates of the FDCA, the company will recall all adulterated products made and sold on or after February 10, 2022.
In a written statement, Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, noted that “Drug manufacturers have a responsibility to comply with requirements designed to ensure drug quality and safety …. The Justice Department will continue to work closely with the FDA and take action against manufacturers who fail to meet this responsibility.”
The claims resolved by the consent decree are allegations only, and there has been no determination of liability.
Think they’ll finally come clean?
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