FDA Inspection 581731 — Kenneth A. Pettine, MD
The FDA completed an inspection of Kenneth A. Pettine, MD on March 30, 2009 in Johnstown, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Johnstown, CO (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |
| 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 |
| 2985 | 21 CFR 812.140(a)(3)(ii) | Investigator records of relevant observations inadequate |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |