Metallic Particulate Problems Spur Form 483 for Alkermes’ Ohio Plant

Employees at Alkermes’ Wilmington, Ohio, facility repeatedly found metallic particles in drug product samples during testing, but remediation efforts were 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. This creates a situation in which in-process specifications are not consistent with drug product final specifications, according to the form.
Drug GMP Report