FDA 483 - Amgen, Inc.
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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.
- Company
- Amgen, Inc.
- Product Type
- Drugs
ID · 0f69de0e-3c79-4e80-8482-84801428e3f1