Investigator Details
Tamil Arasu
Investigation Details
Last Issued Date
June 21, 2024
No. of 483’s Issued
since 2023
6
Warning Letters Issued
1
Detailed Analysis
Approach:
Investigator Tamil Arasu prioritizes in-depth investigation of discrepancies. He scrutinizes laboratory controls, looking for inconsistencies and uncontrolled procedures at discretion of analysts.
Profile:
FDA Investigator Tamil Arasu frequently looks for traceability in incident management and expects scientifically sound and consistent methods in laboratory controls. His key interest is in documentation of discrepancies and in the scientific validity and consistency of laboratory controls.
Top Process Types:
- Investigations
- Process Validation
- Document Management
- Cleaning Validation
- CAPA
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