FDA 483 - Amgen Manufacturing Ltd - February 27, 2020

An FDA inspection of Amgen Manufacturing, Limited (AML) in Juncos, PR, revealed significant deficiencies in quality control systems for drug substance manufacturing. The firm failed to adequately investigate critical utility and environmental monitoring excursions, and lacked assurance that critical equipment remained in a validated state. Additionally, there were issues with the qualification of clean utilities and the effectiveness of cleaning procedures for product-contact equipment.