FDA Inspection
MercyOne North Iowa Medical Center IRBMercyOne North Iowa Medical Center IRB – FDA Inspection, Jun 21, 2019
Record Details
This FDA Inspection record concerns MercyOne North Iowa Medical Center IRB, with an inspection on June 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shalonda C. Clifford (Issuing Officer)
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ID · c7b1615f-9372-4306-9037-6a66183f1781
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093700
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
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Other FDA inspections of MercyOne North Iowa Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 21, 2010 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for MercyOne North Iowa Medical Center IRB
- FDA Inspection 863041 - 2014-01-16
- FDA Inspection 643582 - 2010-01-21
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