FDA Inspection
East Tennessee Children's Hospital IRBEast Tennessee Children's Hospital IRB – FDA Inspection, Jun 26, 2017
Record Details
This FDA Inspection record concerns East Tennessee Children's Hospital IRB, with an inspection on June 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bd4d6e3e-99e0-4840-8904-fd3803ce3cc7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016144
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.109(b)Information given to subjects
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Other FDA inspections of East Tennessee Children's Hospital IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2022 | NAI | Bioresearch Monitoring | |
| June 28, 2010 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for East Tennessee Children's Hospital IRB
- FDA Inspection 1170725 - 2022-05-19
- FDA Inspection 672457 - 2010-06-28
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