FDA Inspection
Trinity Medical Center-IRBTrinity Medical Center-IRB – FDA Inspection, Jun 24, 2011
Record Details
This FDA Inspection record concerns Trinity Medical Center-IRB, with an inspection on June 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trinity Medical Center-IRB
- Inspection Date
- June 24, 2011
- Product Type
- Devices
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ID · a32ec509-2139-4c81-a762-d8b36ef95168
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 729057
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
11- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(3)Prompt reporting of changes
- 21 CFR 56.108(a)(4)Changes in approved research
Showing 10 of 11 citations.
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Other FDA inspections of Trinity Medical Center-IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2018 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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