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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...

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