Investigator Details
June P Page
Investigation Details
Last Issued Date:
July 31, 2023
Conversion Rate:
11
No. of 483’s Issued :
27
Warning Letters Issued:
3
Detailed Analysis
Approach:
June P Page prioritizes scrutiny of the quality control processes, environmental and personnel monitoring, equipment maintenance, production and process control compliance, testing procedures justification, aseptic processing areas, label control procedures, and adverse drug experience reporting. Inspections are likely to focus heavily on these areas.
Profile:
June P Page is an investigator with a keen interest in quality control procedures, environmental and personnel monitoring, equipment maintenance and calibration, production and process control procedures, testing procedures justification, aseptic processing areas conditions, label control procedures, and adverse drug experience reporting.
Top Process Types:
- Environmental Monitoring
- Contamination Control
- Data Integrity
- Document Management
- Batch Release
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Nephron Sterile Compounding Center LLC
Drugs
Central Admixture Pharmacy Services, Inc.
Outsourcing Facility
