FDA Inspection 712894 — Robert Cywes, M.D.
The FDA completed an inspection of Robert Cywes, M.D. on March 9, 2011 in Palm Beach Gardens, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 9, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Palm Beach Gardens, FL (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 14507 | 21 CFR 812.140(a)(3)(ii) | Investigator adverse effect records inadequate |
| 2974 | 21 CFR 812.110(b) | Investigator non-compliance with agreement/plan/regulations |
| 7012 | 21 CFR 812.100 | Investigator lack of control of investigational devices |