FDA Inspection 683586 — Mark A Klaassen, M.D.
The FDA completed an inspection of Mark A Klaassen, M.D. on Sep 28, 2010 in Elkhart, IN. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 28, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Elkhart, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2973 | 21 CFR 812.110(a) | Subject participation prior to study approval |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 4013 | 21 CFR 58.130(e) | Conduct: changes not obscuring original entries |
| 7012 | 21 CFR 812.100 | Investigator lack of control of investigational devices |