Michael E Maselli
Visit Investigator ProfileInvestigation Details
Detailed Analysis
Michael E Maselli prioritizes assessing the monitoring and control of environmental conditions, equipment calibration, facility maintenance, sterilization efficacy, contamination prevention measures, and stability testing procedures during inspections. He focuses on identifying deficiencies in these areas and emphasizes the need for established written programs and procedures to ensure compliance with quality standards.
Michael E Maselli appears to be a detail-oriented auditor with a focus on contamination control, calibration management, quality risk management, process validation, corrective and preventive actions (CAPA), and stability studies. He seems particularly concerned with the maintenance of environmental conditions, equipment performance, facility maintenance, sterilization efficacy, contamination prevention, and stability testing.
Unlock Insights from 483s & Stay Audit Ready with FDA Tracker
Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies