Investigator Details
Helen Verdel
Investigation Details
Last Issued Date:
October 14, 2022
Conversion Rate:
33
No. of 483’s Issued :
6
Warning Letters Issued:
2
Detailed Analysis
Approach:
Helen Verdel meticulously inspects sterile compounding operations, paying close attention to cleanliness, sterile environment maintenance, and controls during construction activities. She focuses on preventive measures to ensure the safety and sterility of compounded drugs.
Profile:
Helen Verdel is a detail-oriented and thorough auditor with a strong focus on sterile compounding operations, cleanliness, and facility control measures. She prioritizes an aseptic and controlled environment to ensure the sterility and safety of compounded drugs.
Top Process Types:
- Environmental Monitoring
- Batch Records
- CAPA
- Contamination Control
- Data Integrity
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
QuVa Pharma, Inc.
Drugs
