Investigator Details
Madushini Dharmasena
Investigation Details
Last Issued Date:
March 22, 2022
Conversion Rate:
0
No. of 483’s Issued :
1
Warning Letters Issued:
0
Detailed Analysis
Approach:
Madushini Dharmasena emphasizes thorough documentation, robust procedures, and strict adherence to containment and manufacturing standards. Attention to detail and proactive risk mitigation are critical to passing an audit by this investigator.
Profile:
Madushini Dharmasena is a detail-oriented FDA investigator who focuses on containment and prevention of cross-contamination, disinfectant effectiveness, environmental monitoring, investigation procedures, documentation, and manufacturing process compliance.
Top Process Types:
- Deviations
- Quality Risk Management
- Environmental Monitoring
- Complaint Management
- CAPA
