FDA Inspection
Anita P. Courcoulas, MDAnita P. Courcoulas, MD – FDA Inspection, Nov 8, 2011
Record Details
This FDA Inspection record concerns Anita P. Courcoulas, MD, with an inspection on November 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Anita P. Courcoulas, MD
- Inspection Date
- November 8, 2011
- Product Type
- Devices
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ID · 1e68565d-6a61-4224-958e-899c50cb401c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 747008
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
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Other FDA inspections of Anita P. Courcoulas, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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