FDA 483 - Alcami Carolinas Corporation - April 22, 2026

Alcami Carolinas Corporation in Charleston, SC, a drug manufacturer, received a Form FDA 483 with seven observations following an inspection. The findings highlight significant deficiencies in quality systems and laboratory controls, including inadequate employee training, insufficient investigations into discrepancies, and failures in establishing and adhering to written procedures for production, process controls, and data management. These issues collectively point to a need for improved quality oversight and data integrity practices at the facility.