Pharmaceutical Technology spoke with Regulatory Compliance Associates about receiving an FDA 483 and developing a corrective action and preventive action (CAPA) plan.   PharmTech: What are the best practices for developing a detailed CAPA after receiving an FDA 483?   RCA: A CAPA program requires a well-documented system that determines the root cause of non-conformances, system … Continue reading FDA 483 & CAPA Requests