FDA Inspection 1106571 — Kennedy, Philip R.
The FDA completed an inspection of Kennedy, Philip R. on October 16, 2019 in Duluth, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Duluth, GA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 3007 | 21 CFR 812.140(d) | Record retention inadequate |
| 3038 | 21 CFR 812.150(b)(1) | Sponsor evaluation rpt not timely, distributed |
| 3049 | 21 CFR 812.150(b)(5) | Sponsor progress reports for significant risk study |
| 3052 | 21 CFR 812.150(b)(6) | Sponsor notif. of rqst. to return/repair/dispose not made |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |