FDA Inspection
Pozner, Jason N. MDPozner, Jason N. MD – FDA Inspection, Mar 24, 2010
Record Details
This FDA Inspection record concerns Pozner, Jason N. MD, with an inspection on March 24, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Pozner, Jason N. MD
- Inspection Date
- March 24, 2010
- Product Type
- Devices
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ID · d9b5695d-36ba-416b-89d6-a291b917ec20
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 653388
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Pozner, Jason N. MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 4, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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