Investigator Details
Hyung-yul Lee
Investigation Details
Last Issued Date:
May 12, 2023
Conversion Rate:
0
No. of 483’s Issued :
2
Warning Letters Issued:
0
Detailed Analysis
Approach:
Hyung-yul Lee follows a stringent, methodical approach in his inspections. He does not tolerate deviations from SOPs and pays particular attention to sanitization processes, equipment sterility, facilities' cleanliness, and post-intervention inspections.
Profile:
FDA auditor Hyung-yul Lee exhibits a keen focus on the strict adherence to standard operating procedures (SOPs), the integrity and sanitation of equipment and facilities, and rigorous post-intervention checks. His meticulous attention to detail predisposes him to issues that might tend to be overlooked or underestimated in importance during routine operations.
Top Process Types:
- Area Cleaning
- Aseptic Technique
- Cleaning Validation
- Equipment Qualification
- Facility Design
