Investigator Details
Patty P Kaewussdangkul
Investigation Details
Last Issued Date
January 30, 2023
No. of 483’s Issued
since 2023
27
Warning Letters Issued
2
Detailed Analysis
Approach:
Patty P Kaewussdangkul prioritizes scrutinizing sterile product manufacturing processes, batch review procedures, corrective actions and validations in aseptic areas, and employee training. They are keen on thorough documentation and adherence to established procedures.
Profile:
Patty P Kaewussdangkul is a detail-oriented FDA auditor with a strong focus on sterile product manufacturing processes, batch review procedures, corrective actions in aseptic areas, test method validation, and employee training.
Top Process Types:
- Contamination Control
- Laboratory Controls
- Batch Records
- Cleaning Validation
- Batch Release
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