Investigator Details
Scott T Ballard
Investigation Details
Last Issued Date:
April 25, 2023
Conversion Rate:
0
No. of 483’s Issued :
18
Warning Letters Issued:
0
Detailed Analysis
Approach:
Investigator Scott T. Ballard tends to take a rigorous and precise approach. When auditing, he prioritizes the quality of testing procedures, emphasis on aseptic processes, labeling accuracy, and overall equipment and cleanroom hygiene.
Profile:
Scott T. Ballard is an FDA investigator with a keen focus on aseptic procedures, sterility, and endotoxin testing, and cleanroom hygiene. He pays attention to detail, especially in the areas of labeling operations, batch testing, equipment cleaning, clothing of personnel during drug processing, and the use of laboratory determinations. He appreciates stringent monitoring of aseptic processing areas and accurate record-keeping.
Top Process Types:
- Environmental Monitoring
- Equipment Qualification
- CAPA
- Calibration Management
- Contamination Control
Facility Name
Product Type
483 Analysis
Converted
Warning Letter
Fenwal International, Inc.
Devices
