Investigator Details
Melanie M Walker
Investigation Details
Last Issued Date:
February 10, 2023
Conversion Rate:
0
No. of 483’s Issued :
1
Warning Letters Issued:
0
Detailed Analysis
Approach:
Melanie M Walker adopts a thorough and meticulous approach during inspections, prioritizing aseptic processing, personnel training, and inventory control. She closely examines documentation practices and reserve sample management, and expects strict compliance with regulatory standards in these areas.
Profile:
Melanie M Walker is a detail-oriented FDA auditor with a strong focus on aseptic processing, environmental monitoring, personnel training, and documentation practices. She is particularly concerned with inventory control and reserve sample management, and expects strict adherence to regulatory standards in these areas.
Top Process Types:
- Environmental Monitoring
- Contamination Control
- Equipment Qualification
- Data Integrity
- Facility Design
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Nephron Sterile Compounding Center LLC
Drugs
