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

An FDA inspection of Biocon Sdn Bhd, a sterile drug product manufacturer in Iskandar Puteri, Johor, Malaysia, revealed critical deficiencies in preventing microbiological contamination and ensuring product quality. Observations included poor aseptic techniques, inadequate validation of aseptic processes, failures in quality control responsibilities, and insufficient investigation of discrepancies. These findings indicate a significant risk to the sterility and overall quality of drug products manufactured at the facility.