FDA Inspection 821774 — Steven H. Wiener
The FDA completed an inspection of Steven H. Wiener on Mar 1, 2013 in Scottsdale, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 1, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Scottsdale, AZ (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |