Investigator Details
Jay B Shah
Investigation Details
Last Issued Date
June 8, 2022
No. of 483’s Issued
since 2023
3
Warning Letters Issued
0
Detailed Analysis
Approach:
Jay B Shah meticulously inspects aseptic processing areas and places a significant emphasis on the proper functioning of air filtration systems and batch testing for expiration date determination. His approach is thorough and methodical.
Profile:
Jay B Shah is a detail-oriented investigator with a strong focus on aseptic processing areas and environmental monitoring. He prioritizes compliance with air supply filtration requirements and expiration date testing for drug products.
Top Process Types:
- Environmental Monitoring
- Drug Product Containers & Closures
- Facility Design
- Process Control
- Stability Studies
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