FDA 483 - Alcami Carolinas Corporation - February 06, 2026

An FDA inspection of Alcami Carolinas Corporation in Charleston, SC, revealed significant deficiencies in the manufacturing of sterile drug products. Observations included incomplete performance qualification studies for critical equipment, inadequate and untimely investigations into out-of-specification bioburden results, and a deficient environmental monitoring system. The findings indicate a lack of robust controls to ensure the quality and sterility of drug products.