FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - September 27, 2024

An FDA inspection of Biocon Sdn Bhd in Iskandar Puteri, Johor, Malaysia, revealed critical deficiencies in aseptic processing, quality control, and investigation practices. The firm exhibited poor aseptic techniques, inadequate validation of sterile manufacturing processes, and failed to accurately document microbiological results and manage corrective actions effectively. These findings indicate a lack of robust controls necessary to ensure the sterility and quality of drug products.