FDA Inspection 706952 — Thomas K Jones MD - Clinical Investigator
The FDA completed an inspection of Thomas K Jones MD - Clinical Investigator on Jan 18, 2011 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2981 | 21 CFR 812.140(a)(2)(i) | Investigator device accountability inadequate |
| 3028 | 21 CFR 812.150(a)(4) | No approval for investigator change in non-emergency |
| 3035 | 21 CFR 812.150(a)(7) | Investigator report in response to a request |