Investigator Details
Ko U Min
Investigation Details
Last Issued Date:
March 30, 2022
Conversion Rate:
33
No. of 483’s Issued :
3
Warning Letters Issued:
1
Detailed Analysis
Approach:
Ko U Min takes a meticulous approach to inspections, focusing on thorough documentation, compliance with written procedures, and the integrity of quality control and equipment maintenance processes.
Profile:
Ko U Min is a detail-oriented FDA investigator with a strong focus on compliance with written procedures and regulations, thorough documentation, quality control, and equipment maintenance. He also emphasizes the importance of employee training, stability programs, and maintaining the integrity of computer systems.
Top Process Types:
- Document Management
- Investigations
- Data Integrity
- Equipment Qualification
- Equipment Cleaning
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Novel Laboratories, Inc. d.b.a Lupin Somerset
Drugs
