FDA Inspection
Medical Central Health System IRB #1FDA Inspection 755897 - Medical Central Health System IRB #1 - December 07, 2011
Record Details
This FDA Inspection record concerns Medical Central Health System IRB #1, with an inspection on December 7, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 7, 2011
- Product Type
- Devices
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ID · b65a2b05-b7fc-47c4-a2bf-798bf32158c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755897
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.109(f)Continuing review
- 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 |
| March 31, 2010 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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