FDA Inspection 1152464 — Mark R. Newton, M.D.
The FDA completed an inspection of Mark R. Newton, M.D. on September 23, 2021 in Waterloo, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Waterloo, IA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14508 | 21 CFR 812.140(a)(4) | Investigator record of protocol deviations inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2980 | 21 CFR 812.140(a)(1) | Investigator correspondence records inadequate |
| 3027 | 21 CFR 812.150(a)(4) | Investigator non-emergency safety or soundness changes |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |