Amgen manufacturing warning letter
Executive Summary
Amgen resolves manufacturing problems surrounding Kineret (anakinra) July 7, company says. FDA May 9 1warning letter cited Amgen's Boulder, Colo. manufacturing facility; infractions included lack of thorough investigation of filtered purified bulk; construction and expansion of support systems without adequate change control; failure to notify FDA of changes to production process; and exporting product not intended for export...