FDA 483 - Amgen Technology (Ireland) Unlimited Company - September 16, 2025

An FDA inspection conducted from September 8-16, 2025, at Amgen Technology (Ireland) Unlimited Company identified significant deficiencies in its drug product manufacturing operations. The observations, documented in an FDA Form 483, highlighted critical issues primarily related to process controls, equipment validation, and facility maintenance, indicating potential risks to product quality and sterility. Specifically, the inspection found a failure to establish adequate process controls for sterile manufacturing. This included improper handling and assembly of sterile equipment for fill lines, such as opening sterile packaging in non-classified areas and inadequate sanitization, which jeopardized the sterility of critical surfaces. A black particle was also noted on a stopper bowl cover. Furthermore, the facility demonstrated deficient equipment revalidation practices, with sterilization systems not undergoing reoccurring physical and biological evaluations since 2007. Maintenance issues were also observed, including leaks in manufacturing assets and extensive corrosion on stainless steel components in critical areas, compromising their qualified state. A dislodged cleanroom barrier was also noted. These observations indicate a need for Amgen Technology (Ireland) to implement comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices and uphold the identity, strength, quality, and purity of its drug products. The company must address these issues promptly to resolve the concerns raised by the FDA.