Investigator Details
Michael R Shanks
Investigation Details
Last Issued Date
January 19, 2024
No. of 483’s Issued
since 2023
6
Warning Letters Issued
0
Detailed Analysis
Approach:
Michael R Shanks conducts thorough inspections focusing on the execution and adherence to validation activities, facility maintenance, and quality control unit procedures.
Profile:
Michael R Shanks is a detail-oriented auditor with a focus on validation activities and facility/equipment maintenance. He prioritizes the adherence to cGMP production activities and the proper implementation of procedures by the quality control unit.
Top Process Types:
- Contamination Control
- Environmental Monitoring
- Cleaning Validation
- Preventive Maintenance
- Process Validation
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