FDA Inspection 1065782 — Hutchens Thomas MD
The FDA completed an inspection of Hutchens Thomas MD on Sep 13, 2018 in Bismarck, ND. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bismarck, ND (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |