FDA 483 - Alexion Pharma International Operations Unlimited Co. - April 08, 2022

An FDA inspection conducted at Alexion Athlone Manufacturing Facility (AAMF) in Athlone, Ireland, from March 31 to April 8, 2022, revealed several significant observations related to manufacturing and quality control processes. The inspection, carried out by the U.S. Food and Drug Administration, identified practices inconsistent with regulatory expectations for drug substance manufacturing.Key issues included multiple deviations during production, such as failures to adhere to standard operating procedures leading to product loss due to an open valve and an unprompted product transfer error. The facility also used expired materials in production. Furthermore, in-process testing in the Quality Control laboratories was found to be inadequate. This included concerns about reference standard expiry management, a high invalid rate for a critical assay due to system suitability failures, and unresolved issues with growth promotion testing for environmental monitoring plates. Lastly, the cleaning validation for certain equipment was deemed incomplete, with rinse testing results exceeding acceptance criteria and insufficient justification for alternative testing methods.These observations necessitate prompt and comprehensive corrective actions from Alexion Athlone Manufacturing Facility to ensure compliance with Good Manufacturing Practices and to maintain product quality and patient safety. The firm must address the identified deficiencies in production controls, quality testing, and validation practices.