Investigator Details
Yasamin Ameri
Investigation Details
Last Issued Date
August 19, 2022
No. of 483’s Issued
since 2023
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
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