Glossary
Chen Sun
FDA Investigator Details
Chen Sun
Visit Investigator ProfileInvestigation Details
Last Issued Date
August 24, 2021
Conversion Rate
0
% Conversion
No. of 483’s Issued
1
Warning Letters Issued
0
Countries Inspected
Republic of Korea
FDA Investigators having one site common
Detailed Analysis
Approach:
Chen Sun conducts meticulous and in-depth assessments, focusing on the accuracy, completeness, and compliance of documented processes. He pays particular attention to validation procedures and authentication of data integrity.
Profile:
Chen Sun is a detail-oriented and thorough FDA auditor who focuses on quality control processes, analytical testing methods, sampling plans, swabbing methods, disinfectant qualification, microbial contamination, system controls, and data integrity. He is particularly concerned with compliance gaps, undocumented changes, validation issues, and lack of proper documentation.
Top Process Types:
- Contamination Control
- Cleaning Validation
- HVAC
- Environmental Monitoring
- Corrective and Preventive Action (CAPA)
Unlock Insights from 483s & Stay Audit Ready with FDA Tracker
Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies
Get Started Now