FDA Inspection 603567 — Kennedy, Philip R.
The FDA completed an inspection of Kennedy, Philip R. on May 29, 2009 in Duluth, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 29, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Duluth, GA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14510 | 21 CFR 812.150(b)(6) | Sponsor notif. of rqst. to return/repair/dispose not timely |
| 14516 | 21 CFR 812.25(e) | Sponsor's lack of written monitoring procedures |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2930 | 21 CFR 812.42 | Sponsor began study before IRB/FDA approval |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability 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 |
| 7006 | 21 CFR 812.43(c)(5) | No financial disclosure info in investigator agreement |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |