FDA 483 - ALK-Abello, Inc. - June 13, 2025

ALK-Abello, Inc. received a Form 483 following an inspection that revealed significant deficiencies in their aseptic processing operations. Key issues included inadequate validation of sterilization processes, deficient environmental monitoring, and failures in following established procedures for cleaning and contamination prevention. The observations highlight a lack of robust quality control and data integrity practices impacting the sterility assurance of their drug products.