FDA 483 - Nectar Lifesciences Limited - March 10, 2023

An FDA inspection of Nectar Lifesciences Limited identified significant deficiencies in aseptic processing, environmental monitoring, and quality control systems. The firm failed to adequately conduct aseptic process simulations and airflow studies, and did not properly record interventions during manufacturing. Repeated observations highlight a lack of timely investigations into microbial data deviations and market complaints, alongside inadequate training for visual inspectors and insufficient cleaning validation for equipment.