Investigator Details
Edmund F Mrak
Investigation Details
Last Issued Date
June 28, 2023
No. of 483’s Issued
since 2023
14
Warning Letters Issued
1
Detailed Analysis
Approach:
Edmund F Mrak meticulously inspects facility design and contamination control measures, focusing on identifying potential sources of contamination and ensuring adherence to sterile processing requirements. He emphasizes the critical importance of maintaining aseptic conditions in regulated environments.
Profile:
Edmund F Mrak is a meticulous and detail-oriented auditor with a strong focus on facility design, contamination control, and aseptic processing. He prioritizes ensuring proper air quality, prevention of contamination, and maintenance of sterility in critical areas.
Top Process Types:
- Environmental Monitoring
- Contamination Control
- Facility Design
- Document Management
- Drug Product Containers & Closures
Unlock Insights from 483s & Stay Audit Ready with FDA Tracker
Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies
Get Started Now