FDA Inspection
Robert Cywes, M.D.Robert Cywes, M.D. – FDA Inspection, Mar 9, 2011
Record Details
This FDA Inspection record concerns Robert Cywes, M.D., with an inspection on March 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Robert Cywes, M.D.
- Inspection Date
- March 9, 2011
- Product Type
- Devices
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ID · 39ff14a2-ff9b-408f-8477-bbe5d5f4efab
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712894
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of control of investigational devices
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
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Other FDA inspections of Robert Cywes, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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