Metallic Particulate Problems Spur Form 483 for Alkermes’ Ohio Plant

April 6, 2012
Employees at Alkermes’ Wilmington, Ohio, facility repeatedly find metallic particles in drug product samples during testing, but remediation efforts are thwarted by inadequate plant procedures, a Form 483 handed to the global biopharmaceutical company states. During an Aug. 29 to Nov. 4, 2011, inspection, FDA investigators noted particulate profiling samples are collected at the same time and at the same point during the manufacturing process as employees collect finished product samples.
Drug GMP Report