Glossary
James R Montero
FDA Investigator Details
James R Montero
Visit Investigator ProfileInvestigation Details
Last Issued Date
July 31, 2024
Conversion Rate
0
% Conversion
No. of 483’s Issued
2
Warning Letters Issued
0
Countries Inspected
USA, United States
FDA Investigators having one site common
Detailed Analysis
Approach:
James R Montero follows a methodical approach, focusing on the validation and control of manufacturing processes and equipment. He also places importance on the establishment of robust procedures for corrective and preventive actions, as well as the documentation and handling of complaints.
Profile:
James R Montero seems to prioritize validation and control of manufacturing processes, equipment, and documentation. He pays close attention to corrective and preventive actions, cleaning validation, contamination control, and equipment qualification. Additionally, he emphasizes the importance of training management and complaint handling.
Top Process Types:
- Investigations
- CAPA
- Complaint Management
- Sample Testing
- Training Management
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
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