FDA 483 - Bronco Research Services dba inotiv Fort Collins - August 26, 2025

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.