FDA 483 - Amgen, Inc.

An FDA inspection of Amgen Inc.'s drug substance manufacturing facility in Thousand Oaks, CA, revealed two significant observations. The firm's procedural controls and process containment were found inadequate to prevent cross-contamination by a potent biological product, lacking proper risk assessment and cleaning validation. Additionally, equipment was not stored appropriately after cleaning, leading to microbial contamination due to inadequate procedures for post-cleaning handling.