FDA Inspection
UnityPoint Health Des Moines IRBUnityPoint Health Des Moines IRB – FDA Inspection, Aug 11, 2017
Record Details
This FDA Inspection record concerns UnityPoint Health Des Moines IRB, with an inspection on August 11, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e5d5e789-71ae-4714-9a47-8788c4d5108e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021242
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UnityPoint Health Des Moines IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 19, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for UnityPoint Health Des Moines IRB
- FDA Inspection 1178378 - 2022-08-24
- FDA Inspection 725218 - 2011-05-19
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