Li Li

Investigator Li Li emphasizes the importance of procedural compliance and risk management in his audits. He dissects each process to ensure proper documentation and execution, and pays particular attention to how companies handle complaints, adverse events, and potential health risks.

FDA Investigator Li Li has a keen interest in the administration and process execution aspects of medical device companies. He heavily scrutinises indicative procedures such as Complaint Handling, MDR (Medical Device Reports) procedures, CAPA (Corrective and Preventive Action) procedures, the reporting of corrections or removals, and process validation. His observations suggest an emphasis on thorough documentation and traceability, as well as adherence to regulatory reporting requirements. Investigator Li Li also shows a focus on proactive steps to mitigate health risks and prevent recurring failures.