Investigator Details
Jose E Melendez
Investigation Details
Last Issued Date:
February 17, 2023
Conversion Rate:
25
No. of 483’s Issued :
8
Warning Letters Issued:
2
Detailed Analysis
Approach:
Jose E Melendez places a strong emphasis on evidence-based scrutiny, ensuring that discrepancies are thoroughly reviewed and documented, with a clear focus on sterility assurance, environmental monitoring, computer system controls, quality control adherence, and regulatory reporting. He is meticulous in identifying deficiencies and expects comprehensive corrective and preventive actions.
Profile:
Jose E Melendez is a detail-oriented FDA auditor who focuses on thorough evidence of discrepancy review, sterility assurance, environmental monitoring, computer system controls, complaint handling procedures, quality control unit adherence, laboratory record-keeping, and regulatory reporting requirements.
Top Process Types:
- Data Integrity
- Document Management
- Investigations
- Batch Records
- Complaint Management
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Intas Pharmaceuticals Limited
Drugs
Cipla Limited
Drugs
