Investigator Details
Ruben C Quintana
Investigation Details
Last Issued Date:
December 22, 2023
Conversion Rate:
0
No. of 483’s Issued :
2
Warning Letters Issued:
0
Detailed Analysis
Approach:
Ruben C Quintana meticulously reviews quality control procedures, aseptic processing documentation, building construction and IT controls. He prioritizes accuracy and integrity in computer data and laboratory sampling plans to ensure product quality.
Profile:
Ruben C Quintana is a detail-oriented FDA investigator who places a strong emphasis on the quality control unit, aseptic processing areas, building size and construction, computer and related systems, equipment design and environmental monitoring. He is particularly concerned with the accuracy and integrity of computer input and output data, as well as the laboratory controls and sampling plans.
Top Process Types:
- Environmental Monitoring
- Investigations
- Document Management
- Data Integrity
- Contamination Control