483
Bronco Research Services dba inotiv Fort CollinsBronco Research Services dba inotiv Fort Collins – FDA 483, Aug 26, 2025
Record Details
Bronco Research Services dba inotiv Fort Collins received a Form 483 with four observations related to nonclinical laboratory studies. The inspection revealed significant issues with data accuracy and verification, adherence to study protocols, and the quality assurance unit's review of final reports. Additionally, final study reports were found to be incomplete, lacking required signed professional reports.
- Inspection date
- August 26, 2025
- Product type
- other
- Office
- Denver District Office
- Person
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ID · acfe3fc8-383d-4e87-9e38-7c5bac775c35
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