FDA 483 - Amgen, Inc.

Amgen Inc. in Thousand Oaks, CA, a drug substance manufacturing facility, was cited for multiple deficiencies related to quality control, risk assessment, and manufacturing processes during an FDA inspection. Key issues included inadequate investigations into cell bank stability failures, deficient raw material quality assessment leading to viral contamination, and insufficient validation and record-keeping practices. These observations indicate a need for improved quality systems to ensure product sterility and integrity.