Xiaohui Shen
Investigation Details
Detailed Analysis
Shen adopts a meticulous and in-depth approach in the analysis of an establishment. He makes it a point to inspect critical areas such as ISO 5 classified areas carefully, and demands clear and comprehensive documentation to validate an establishment's cleanliness, maintenance, and control procedures.
FDA investigator Xiaohui Shen appears to have a keen eye for the cleanliness of the facility, emphasizing especially on equipment sanitation and maintenance, the integrity of the controlled environment, and contamination control. Shen is particularly meticulous about getting these elements right, prioritizing verifiable documentation when assessing an establishment's operations, especially in high-risk areas such as ISO 5 classified aseptic processing areas.
- Document Management
- Environmental Monitoring
- Batch Records
- Contamination Control
- Training Management
