FDA Inspection 1009898 — Cheryl Roth, PhD RN
The FDA completed an inspection of Cheryl Roth, PhD RN on April 26, 2017 in Scottsdale, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Scottsdale, AZ (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 3063 | 21 CFR 812.140(a)(3)(iii) | Investigator records of exposure to device inadequate |