FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - July 05, 2019

An FDA inspection of Biocon Sdn Bhd in Iskandar Puteri, Malaysia, revealed significant deficiencies in quality control, investigations, aseptic processing, and laboratory controls. The firm failed to adhere to established procedures for deviation management, CAPA effectiveness, and data integrity, with several issues noted as repeat observations. These findings indicate systemic problems in maintaining drug product quality and sterility.