Tracy K Li
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Detailed Analysis
Tracy K Li takes a comprehensive, end-to-end approach to inspection, focusing on every stage from raw material acquisition to final product verification. His approach sees him scrutinize processes, controls, and sterile products. He is particularly keen on checking environmental conditions, compliance with written procedures, and quality control mechanisms, among other factors.
Tracy K Li, an FDA auditor, has shown predominantly interest in aseptic techniques, microbial contamination, and sterile drug production. He is very observant of the quality control methods, environmental and personnel monitoring, lab testing and labeling practices. Besides, he also pays considerable attention to the stability testing program and the use of components in compounding sterile drugs.
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