FDA 483 - Biocon Biosphere Limited - November 07, 2025

Biocon Biosphere Limited, a drug substance manufacturer, was inspected and cited for two significant observations. The firm failed to establish appropriate qualifications and controls for computerized systems, specifically regarding the validation and control of electronic master batch records. Additionally, written procedures for equipment cleaning were found to be inadequately described or followed, with cleaning limits lacking scientific justification and deficiencies in swab sampling methods.