FDA Inspection
University Hospitals Cleveland Medical Center IRBUniversity Hospitals Cleveland Medical Center IRB – FDA Inspection, Sep 19, 2017
Record Details
This FDA Inspection record concerns University Hospitals Cleveland Medical Center IRB, with an inspection on September 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 19, 2017
- Product Type
- Devices
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ID · d4657254-3680-4c92-9554-6de3d0119a08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1026089
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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Other FDA inspections of University Hospitals Cleveland Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2021 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 6, 2011 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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