FDA EIR - Amgen, Inc. - December 13, 2019

A routine FDA Current Good Manufacturing Practice (cGMP) inspection of Amgen, Inc.'s Thousand Oaks, California facility took place from December 9-13, 2019. This surveillance inspection, conducted under CPGM 7356.002M, focused on four licensed biological drug substances: epoetin alfa (Epogen), erenumab (Aimovig), adalimumab-atto (AMJEVITA), and bevacizumab-awwb (MVASI). The inspection culminated in a single FDA Form 483 observation. The primary issue was that procedures for equipment cleaning and maintenance were deficient, specifically regarding the lack of demonstrated disinfection efficacy after microbiological excursions (e.g., mold) were found in controlled areas, failing to verify cleanliness immediately before use. This was referenced under 21 CFR 211.67(b)(6). Further discussions with management highlighted several concerns: a lack of comprehensive training for quality control and quality assurance staff on specialized topics like elemental impurity testing, an inadequate elemental impurity testing plan that only covered drug product batches and not drug substances, and the absence of a structured program for deep cleaning and inspection of heavy equipment areas. Amgen committed to implementing corrections, including more frequent and thorough cleaning, enhanced environmental monitoring, and improved training across all relevant sites. No samples were collected, and no refusals were documented during the inspection.