FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - July 20, 2023

Biocon Sdn Bhd, a drug manufacturer in Iskandar Puteri, Malaysia, was cited for significant deficiencies in its aseptic processing, quality control, and quality system. Repeat observations included failures in preventing microbiological contamination, inadequate investigations into batch failures and OOS results, and insufficient procedures for maintaining aseptic conditions. The inspection also highlighted issues with method validation, employee training, risk analysis for device components, and CAPA documentation, indicating a broad lack of control over critical manufacturing and quality processes.