Investigator Details
Damaris Y Hernandez
Investigation Details
Last Issued Date
June 16, 2022
No. of 483’s Issued
since 2023
1
Warning Letters Issued
0
Detailed Analysis
Approach:
Damaris Y Hernandez prioritizes thorough examination of aseptic processing areas, validation of software, completeness of manufacturing instructions, and compliance with drug product labeling requirements during inspections.
Profile:
Damaris Y Hernandez is a detail-oriented FDA auditor with a strong focus on aseptic processing, validation of software, completeness of manufacturing instructions, and drug product labeling.
Top Process Types:
- Label & Packaging Controls
- Batch Records
- Computer System Validation
- Data Integrity
- Environmental Monitoring
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