FDA 483 - Biocon Biologics Limited - July 26, 2024

During an inspection conducted from July 15-26, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Biocon Biologics Limited, a drug substance and drug product manufacturer located in Bengaluru, India. The inspection revealed ten significant observations concerning compliance with Current Good Manufacturing Practice (cGMP) regulations.

Key issues included critical deficiencies in aseptic processing validation, where airflow visualization studies for sterile filling lines did not meet acceptance criteria or established protocols, leading to potential contamination risks. Furthermore, operators were observed failing to adhere to aseptic procedures, such as improper hand sanitization, unauthorized crossings of critical areas, and incorrect handling of sterile materials.

The FDA also noted significant lapses in laboratory controls, including the unauthorized reprocessing of chromatograms to alter Out-of-Specification results, inconsistent application of system suitability criteria, and the frequent use of manual data integration without proper justification. Data integrity was compromised by unreported failing non-viable particle count data, overwritten electronic records, and inadequate audit trail reviews for computerized systems.

Other observations highlighted insufficient investigations into deviations, recurring equipment malfunctions, inadequate environmental monitoring, and flawed disinfection practices. The firm lacked robust procedures for identifying particulate sources and faced issues with illegible labeling of cGMP materials. Biocon Biologics Limited is required to respond to these observations with a comprehensive plan of corrective and preventive actions to ensure product quality and patient safety.