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

Source: https://www.keypedia.com/records/483/bronco-research-services-dba-inotiv-fort-collins/91c7dbc9-4876-4427-8015-31a2c5c8d2b9

> FDA 483 for Bronco Research Services dba inotiv Fort Collins on August 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bronco Research Services dba inotiv Fort Collins
- Inspection Date: 2025-08-26
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection at Bronco Research Services dba inotiv Fort Collins, a non-clinical laboratory, conducted from August 12-26, 2025, identified four critical observations related to regulatory non-compliance, notably within Good Laboratory Practice (GLP) principles. First, the study director failed to accurately record and verify experimental data. Issues included inaccurately reported urinalysis results (e.g., specific values simplified), missing microscopic exam findings, undocumented blood sample conditions, and absent raw data from vendors. Final reports also lacked complete event descriptions or sufficient detail in raw data records. Second, non-clinical studies deviated from protocols. Observed deviations included critical blood collection timepoint variances and improper test article preparation schedules. These protocol breaches lacked appropriate documentation, amendments, or impact discussions in final reports, indicating poor study execution control. Third, the Quality Assurance Unit (QAU) failed to ensure final study report accuracy against raw data. Numerous discrepancies were found despite QAU audits, such as unreported medication, inconsistent clinical observations, factual errors (e.g., animal status, dates), and incorrect expiration data. This highlights systemic oversight weaknesses. Finally, final study reports omitted signed and dated contributions from all involved scientists, including veterinarian evaluations, hindering comprehensive study documentation. Under the Federal Food, Drug, and Cosmetic Act, Bronco Research Services must submit a comprehensive response outlining corrective and preventive actions to address these serious findings and ensure future regulatory compliance for non-clinical studies.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/bronco-research-services-dba-inotiv-fort-collins/f8688233-9b69-4665-bda8-51e8d44924ea

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face