FDA 483 - Biocon Biologics Limited - August 26, 2022

This FDA Form 483 report details significant deficiencies at Biocon Biologics Limited's drug substance manufacturing facilities, primarily concerning contamination control, facility maintenance, and aseptic processing. Inspectors observed inadequate environmental controls in manufacturing areas, poor aseptic techniques during downstream processing, and a lack of assurance regarding raw material quality and cleaning effectiveness. The report also highlights critical issues with data integrity, supervisory oversight, and the suitability of water and steam systems, indicating a broad failure in quality management.