FDA Inspection
Medical Central Health System IRB #1FDA Inspection 653944 - Medical Central Health System IRB #1 - March 31, 2010
Record Details
This FDA Inspection record concerns Medical Central Health System IRB #1, with an inspection on March 31, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 31, 2010
- Product Type
- Devices
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ID · b6cabc41-216e-4370-854d-7d6c6e5025dd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 653944
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(b)Information given to subjects
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Medical Central Health System IRB #1
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 7, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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