FDA Inspection
Centra Health Inc IRBCentra Health Inc IRB – FDA Inspection, Mar 29, 2013
Record Details
This FDA Inspection record concerns Centra Health Inc IRB, with an inspection on March 29, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Centra Health Inc IRB
- Inspection Date
- March 29, 2013
- Product Type
- Devices
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ID · a8ab530d-d979-4d30-9bf8-d828e6a64033
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 824870
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.107(f)Invited individual allowed to vote with IRB
- 21 CFR 56.107(a)At least five members with varying backgrounds
- 21 CFR 56.110(b)Research not eligible for expedited review
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Other FDA inspections of Centra Health Inc IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2019 | NAI | Bioresearch Monitoring | |
| February 15, 2011 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 14, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Centra Health Inc IRB
- FDA Inspection 1109551 - 2019-10-25
- FDA Inspection 710134 - 2011-02-15
- FDA Inspection 611682 - 2009-09-14
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