FDA 483 - Amgen Manufacturing Ltd - July 05, 2023

Amgen Manufacturing Ltd in Juncos, PR, was cited with three observations during an FDA inspection. The firm demonstrated inadequate control procedures for manufacturing processes, specifically regarding alarm management during visual inspection. Additionally, deficiencies were noted in the drug product stability program, including delayed study initiation and insufficient monitoring of contract manufacturing sites. Finally, the facility experienced repeated pest control failures, leading to numerous infestations in critical manufacturing and storage areas.