Amgen, Inc. – FDA 483

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.