FDA Inspection 662258 — Domenick T. Zero, Dds,ms
The FDA completed an inspection of Domenick T. Zero, Dds,ms on May 17, 2010 in Indianapolis, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 17, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 3021 | 21 CFR 812.150(a)(1) | Investigator report of unanticipated adverse effects |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |
| 7231 | 21 CFR 50.20 | Consent not obtained, exceptions do not apply |
| 7363 | 21 CFR 50.55(f) | Documentation of permission by parents or guardian |