FDA 483 - Biocon Biologics Limited - September 19, 2019

Biocon Biologics India Limited in Bangalore, India, was cited for significant deficiencies in its drug substance and drug product manufacturing operations. The inspection revealed incomplete root cause investigations for out-of-specification results, ineffective corrective actions for microbial excursions, and inadequate equipment qualification and maintenance programs. Furthermore, the firm demonstrated a lack of quality oversight, and its written procedures were either inadequate or not followed, leading to multiple batch rejections and a deficient pest control management system.