FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - February 21, 2020

Biocon Sdn Bhd in Iskandar Puteri, Malaysia, received a Form 483 with three observations highlighting significant deficiencies in quality control and manufacturing processes for sterile drug products. The firm failed to thoroughly investigate unexplained discrepancies in batch records related to environmental monitoring interventions and lacked adequate procedures to prevent microbiological contamination. Additionally, the quality control unit demonstrated failures in its responsibilities, including missing equipment qualifications and prematurely closing a CAPA.