FDA Inspection
Porter, Littleton and Parker Adventist Hospitals Joint IRBPorter, Littleton and Parker Adventist Hospitals Joint IRB – FDA Inspection, Dec 18, 2012
Record Details
This FDA Inspection record concerns Porter, Littleton and Parker Adventist Hospitals Joint IRB, with an inspection on December 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 18, 2012
- Product Type
- Devices
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ID · f8276dff-7a3d-49f6-a752-959e37e1d378
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811086
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.107(a)At least five members with varying backgrounds
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Other FDA inspections of Porter, Littleton and Parker Adventist Hospitals Joint IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 11, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Porter, Littleton and Parker Adventist Hospitals Joint IRB
- FDA Inspection 981513 - 2016-05-19
- FDA Inspection 662070 - 2010-05-11
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