Investigator Details
Peter W Kim
Investigation Details
Last Issued Date:
January 26, 2024
Conversion Rate:
0
No. of 483’s Issued :
1
Warning Letters Issued:
0
Detailed Analysis
Approach:
Peter W Kim''s approach involves a meticulous examination of root cause analyses, calibration management, batch manufacturing deviations, and data integrity measures. He places strong emphasis on evidence of systematic CAPA activities to target the root cause of repeated equipment-related failures.
Profile:
Peter W Kim is a detail-oriented FDA auditor who places a strong emphasis on root cause analysis, data integrity, and adherence to GMP requirements. He expects thorough investigations into deviations, comprehensive calibration management, and robust CAPA activities aimed at addressing equipment-related failures.
Top Process Types: