FDA EIR - Amgen Manufacturing Ltd - September 27, 2019

Amgen Manufacturing Limited in Juncos, PR, underwent an FDA Pre-Approval inspection from September 23-27, 2019, under the Food, Drug, and Cosmetic Act. The inspection focused on the transfer of manufacturing operations for licensed biologics, Amjevita and MVASI. Two primary observations were identified: First, batch production records for both products lacked complete information regarding critical process parameters, such as blend speed and temperature, during drug substance blending. This was contrary to 21 CFR 211.188, which requires comprehensive batch documentation. Management indicated these parameters were not consistently documented because equipment was qualified and preset, but FDA emphasized the necessity for ongoing record-keeping. Second, the Process Performance Qualification (PPQ) for MVASI vial filling lacked complete documented evidence for key operational parameters obtained via data processing tools, violating 21 CFR 211.110(a). Although data was processed, the confirmatory output was not retained, hindering validation verification. Verbal deficiencies included inadequate facility maintenance and insufficient documentation for pre-construction activities. Amgen also provided inaccurate information, initially limiting access to manufacturing areas and the use of cameras. Management committed to submitting a written response to the Office of Pharmaceutical Quality Operations (OPQO) within 15 days.