FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Illinois Compounder Smacked With Consent Decree Over Violations at Multiple Sites

May 31, 2019
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Illinois-based compounder PharMedium Services has been ordered to shut down operations at its Tennessee site after repeated warnings from the FDA to clean up its act.

The consent decree entered by a federal judge, which also names two senior executives—Scott Aladeen, the company’s president, and  Warren Horton, vice president for quality and R&D—bars the firm’s Memphis, Tennessee facility from holding, manufacturing or distributing drugs. The ban will stay in effect until the site resolves its issues and receives the all clear from the FDA.

The company—which produces sterile injectable drugs like narcotic analgesics, anesthetics and labor inducers—voluntarily halted operations at its Mississippi facility, and its New Jersey and Texas facilities will be required to bring in an outside expert to ensure they comply with the law.

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