FDA 483 - Genzyme Corporation - March 18, 2024

An FDA inspection of Genzyme Corporation in Ridgefield, NJ, a drug manufacturer, identified a significant issue regarding procedures to prevent microbiological contamination of sterile drug products. Specifically, the firm's smoke studies for the aseptic filling of Lovenox syringes were found to be inadequate, failing to demonstrate unidirectional airflow during critical interventions and assess observed air currents. This raises concerns about the sterility assurance of their products.