Investigator Details
Yasamin Ameri
Investigation Details
Last Issued Date:
August 19, 2022
Conversion Rate:
12
No. of 483’s Issued :
8
Warning Letters Issued:
1
Detailed Analysis
Approach:
Yasamin Ameri meticulously examines aseptic processing areas, manufacturing process controls, equipment design, and data accuracy. She prioritizes regulatory compliance and looks for thorough procedures in reviewing discrepancies.
Profile:
Yasamin Ameri is a detail-oriented FDA auditor with a focus on aseptic processing, manufacturing process control, equipment design, data accuracy, and regulatory compliance. She values thorough review of discrepancies and secure storage of backup data.
Top Process Types:
- Data Integrity
- Data Backup and Recovery
- Computer System Validation
- Deviations
- Audit Management
