Amgen Manufacturing Ltd – FDA EIR, Apr 29, 2011

A routine FDA inspection of Amgen Manufacturing Limited, Inc. in Juncos, PR, took place from April 18 to April 29, 2011. This comprehensive inspection, guided by CP 7356.002M for licensed biologic products, identified eight significant deficiencies, leading to the issuance of an FDA Form 483. Key violations centered on quality system breakdowns, including the failure to thoroughly investigate identified defects, such as glassware issues, before closing investigations. The firm also failed to timely investigate all complaints per written procedures and the Quality Control Unit did not implement adequate review and approval processes for sterile garb used in aseptic areas. Further issues involved insufficient verification of supplier Certificate of Conformance specifications (e.g., endotoxin levels), non-adherence to written procedures for receiving drug product containers, and the absence of established investigation limits for rejected units from semi-automated inspection. Additionally, inspection personnel did not consistently follow written procedures, and time limits for the media chill phase of Aranesp drug substance manufacture were unestablished and unverified. Amgen committed to developing and submitting a written response detailing corrective actions for all observations within two weeks of the inspection's close, with some immediate corrections implemented during the inspection.