# FDA 483 - Kennedy, Philip R. - October 16, 2019

Source: https://www.keypedia.com/records/483/kennedy-philip-r/0a5abf4a-390b-44a5-9299-e4a8fde07481

> FDA 483 for Kennedy, Philip R. on October 16, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Kennedy, Philip R.
- Inspection Date: 2019-10-16
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Philip R. Kennedy, M.D., PhD, Sponsor-Investigator, was inspected regarding an investigational device study and received nine observations. The inspection revealed significant deficiencies in IRB oversight, study monitoring, informed consent, device accountability, adverse event reporting, record keeping, and financial disclosure for sub-investigators. Several observations were repeats from a prior inspection, indicating persistent non-compliance.

## Related Documents

- [WARNING_LETTER - 2019-10-16](https://www.keypedia.com/records/warning_letter/kennedy-philip-r/aa7907c6-4fc0-4521-8bdc-8a4dd33b3821)

## Related Officers

- [investigator](https://www.keypedia.com/people/sereen-g-morgan-murray/1900ad73-5999-471e-8f74-63627bd1aa2a)
- [Vanessa E. Coulter](https://www.keypedia.com/people/vanessa-e-coulter/add8407c-0df8-43ed-9f5a-8063880ce638)

Company: https://www.keypedia.com/companies/kennedy-philip-r/7b46aa3d-fbf5-4657-9013-65abb06f4bfe

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7