FDA Inspection
Gordon, Stephen W. MDGordon, Stephen W. MD – FDA Inspection, Jul 13, 2010
Record Details
This FDA Inspection record concerns Gordon, Stephen W. MD, with an inspection on July 13, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gordon, Stephen W. MD
- Inspection Date
- July 13, 2010
- Product Type
- Devices
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ID · 0d0fb24b-93c3-4c15-9447-e5cc7a637e17
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 667734
- 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 812.150(a)(2)Investigator report of IRB withdrawal of approval
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
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