Mylan NV, of Hertfordshire, UK, received an FDA warning letter citing conditions at three of its drug manufacturing facilities in Bangalore, India, including two that were part of its 2013 acquisition of Agila Specialties. Inspections of the plants revealed contamination risks in aseptic areas stemming from torn gloves and gowns and workers’ behavior, such as bumping into each other in fill areas or leaving barriers open while performing other duties. A number of other problems were cited, including the failure to determine the root cause of contaminated product or defects. Several of the violations were recurrent and long-standing, the FDA said. Thus, the problems noted by the inspectors “raise questions about the ability of [Mylan’s] current corporate quality system to achieve overall compliance” with good manufacturing practices, according to the letter. Although acknowledging that Mylan acquired the Agila facilities recently, the FDA said a Sept. 9, 2013, warning letter should have put the drugmaker on notice about the problems at the plants. “Even without this warning letter, your corporate quality system should have detected and corrected the forgoing violations without FDA intervention,” the agency concluded.
Sen. Joe Manchin (D-W.Va.) sent a letter Monday to acting FDA Commissioner Stephen Ostroff condemning the agency’s decision last week to approve Purdue Pharma LP’s Oxycontin (oxycodone hydrochloride) for use for children as young as 11. In the letter, the senator expressed his disgust with what he called the FDA’s “foolish and deadly action.” Noting that the agency is required to convene an advisory committee on matters that are of significant public interest, highly controversial or in need of a specific type of expertise, Manchin questioned why no advisory committee was consulted before the FDA approved the pediatric use. He informed Ostroff that he would be calling for a Senate investigation into the approval, as well as other FDA decisions to approve opioid drugs. “I cannot sit by while an agency of the federal government facilitates the poisoning of our children and their parents and grandparents,” Manchin said.