Andrew Le
Investigation Details
Detailed Analysis
Andrew Le follows a methodical approach, emphasizing meticulous examination of procedures, documentation, and systems related to microbiological control and aseptic processing. He pays close attention to compliance with labeling requirements and seeks evidence of a strong, empowered quality control unit.
Andrew Le is a detail-oriented FDA auditor who has a strong focus on microbiological contamination, aseptic processing, environmental monitoring, and personnel training. He prioritizes the thorough investigation of deviations, the effectiveness of cleaning and monitoring systems, and the adherence to proper labeling requirements. He expects a high level of competence and authority within the quality control unit to ensure compliance with regulatory standards.
- Environmental Monitoring
- Contamination Control
- Document Management
- Training Management
- Complaint Management
