FDA Inspection 799601 — Mark A Klaassen, M.D.
The FDA completed an inspection of Mark A Klaassen, M.D. on Sep 18, 2012 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 18, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Elkhart, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |