Amgen, Inc. – FDA 483, Mar 13, 2025

Amgen, Inc. in Thousand Oaks, CA, was cited for significant deficiencies across its manufacturing and quality control operations. Observations included failures in preventing microbiological contamination during sterile filling, inadequate investigation of discrepancies in visual inspection qualification records, and deficient microbial examination of in-process materials. Additionally, the firm lacked proper systems and training to ensure compliance with DSCSA verification requirements.