FDA Inspection
Brooke R. Seckel, M.D.Brooke R. Seckel, M.D. – FDA Inspection, Mar 25, 2014
Record Details
This FDA Inspection record concerns Brooke R. Seckel, M.D., with an inspection on March 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brooke R. Seckel, M.D.
- Inspection Date
- March 25, 2014
- Product Type
- Devices
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ID · 2b09c7cb-e79b-442a-b6fe-0fcea7f0f0a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 872182
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(a)(5)Additional investigator records FDA requires
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Other FDA inspections of Brooke R. Seckel, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 4, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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