FDA Inspection 898991 — William C. Domb, DMD
The FDA completed an inspection of William C. Domb, DMD on October 16, 2014 in Upland, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 16, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Upland, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |
| 2997 | 21 CFR 812.140(b)(4)(ii) | Sponsor records re non-significant risk status inadequate |
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7384 | 21 CFR 50.25(b)(1) | Statement of risks |
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7390 | 21 CFR 50.25(a)(4) | Alternate procedures, courses of treatment |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |
| 7658 | 21 CFR 50.25(b)(2) | Termination by investigator |
| 7659 | 21 CFR 50.25(a)(6) | Compensation, medical treatment in event of injury |