Yun Wu will meticulously review risk assessments, manufacturing process monitoring, and contamination control procedures. He will prioritize the investigation of discrepancies and non-compliance with procedures, as well as the adequacy of root cause analysis and CAPA implementation. Additionally, he will thoroughly inspect microbial control measures, hold time studies, and electronic data controls. Facility design, maintenance, and labeling will also be scrutinized for their impact on product quality and safety.

Yun Wu is a detail-oriented FDA auditor with a strong focus on manufacturing processes, contamination control, root cause analysis, and CAPA implementation. He prioritizes adherence to written procedures, procedural controls for electronic data, and facility and equipment design, maintenance, and labeling. Yun Wu is particularly concerned with cross-contamination risk assessment, monitoring and control of manufacturing processes, material management systems, cleaning and sanitization procedures, microbial control, and compliance with written procedures. He expects thorough root cause analysis and effective CAPA implementation to address discrepancies. Additionally, he pays close attention to the design and maintenance of facilities and equipment to ensure quality and safety.