Glossary
Hyung-yul Lee
FDA Investigator Details
Hyung-yul Lee
Visit Investigator ProfileInvestigation Details
Last Issued Date
May 12, 2023
Conversion Rate
0
% Conversion
No. of 483’s Issued
2
Warning Letters Issued
0
Countries Inspected
Korea (the Republic of), USA
FDA Investigators having one site common
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:
- Cleaning Validation
- Process Validation
- Preventive Maintenance
- Equipment Qualification
- Aseptic Technique
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
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