FDA 483 - Alcami Carolinas Corporation - April 05, 2024

An FDA inspection of Alcami Carolinas Corporation, a sterile drug manufacturer in Charleston, SC, revealed a significant issue within its laboratory control system. The firm failed to follow established specifications and test procedures, leading to analyst errors during testing runs for a Sodium Chloride Diluent batch. These errors resulted in an out-of-specification value, indicating a breakdown in adherence to training and procedural guidelines.