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Home » Metallic Particulate Problems Spur Form 483 for Alkermes’ Ohio Plant
Metallic Particulate Problems Spur Form 483 for Alkermes’ Ohio Plant
April 2, 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.