# FDA 483 - Timothy F. Burns, MD, PhD - September 07, 2023

Source: https://www.keypedia.com/records/483/timothy-f-burns-md-phd/2bf60b67-a72f-4b4e-aa29-9f934e849ccf

> FDA 483 for Timothy F. Burns, MD, PhD on September 07, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Timothy F. Burns, MD, PhD
- Inspection Date: 2023-09-07
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Timothy F. Burns, MD, PhD, a clinical investigator in Pittsburgh, PA, revealed significant deviations from the investigational plan. The firm failed to follow the study protocol regarding investigational product dose adjustments, performance of required safety tests, and timely reporting of serious adverse events. These findings indicate a lack of adherence to clinical trial protocols.

## Related Officers

- [Cynthia L. Rakestraw](https://www.keypedia.com/people/cynthia-l-rakestraw/ca138abf-e5d4-43ca-b9d2-79ea6294a8c8)

Company: https://www.keypedia.com/companies/timothy-f-burns-md-phd/17990185-6b70-4fae-a5a7-0635ec36c048

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8