FDA Inspection
Nebraska Methodist Hospital IRBNebraska Methodist Hospital IRB – FDA Inspection, Jun 12, 2025
Record Details
This FDA Inspection record concerns Nebraska Methodist Hospital IRB, with an inspection on June 12, 2025, issued by the Kansas City District Office, covering medical devices & rad health.
- Inspection Date
- June 12, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 7cc897a7-9876-472d-b36d-39d7ecb3bdb8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1272497
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.106(e)Changes in contact or chairperson information
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Other FDA inspections of Nebraska Methodist Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Nebraska Methodist Hospital IRB
- FDA Inspection 961417 - 2016-02-17
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