Investigator Details
Dustin M James
Investigation Details
Last Issued Date
May 20, 2022
No. of 483’s Issued
since 2023
1
Warning Letters Issued
0
Detailed Analysis
Approach:
Dustin M James conducts thorough inspections of aseptic processing areas and cleanrooms, paying close attention to the segregation of production areas and the use of proper disinfection and sterilization practices.
Profile:
Dustin M James is a detail-oriented FDA auditor with a strong focus on aseptic processing and cleanroom practices. He prioritizes the segregation of production areas, proper disinfection of materials and supplies, and the use of sporicidal agents in cleanrooms.
Top Process Types:
- Contamination Control
- Environmental Monitoring
- Area Qualification
- Area Cleaning
- Equipment Cleaning
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