FDA Inspection 574553 — Thomas K Jones MD - Clinical Investigator
The FDA completed an inspection of Thomas K Jones MD - Clinical Investigator on Mar 19, 2009 in Seattle, WA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |