FDA Inspection
Seattle Children's Hospital IRBSeattle Children's Hospital IRB – FDA Inspection, Jan 27, 2010
Record Details
This FDA Inspection record concerns Seattle Children's Hospital IRB, with an inspection on January 27, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 27, 2010
- Product Type
- Devices
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ID · 45a564a1-bcd5-48e3-be21-b262fcbf9e92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 645966
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
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Other FDA inspections of Seattle Children's Hospital IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2026 | Not classified | Seattle District Office | Bioresearch Monitoring: Human Drugs |
| January 10, 2020 | NAI | Bioresearch Monitoring | |
| December 5, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Seattle Children's Hospital IRB
- FDA Inspection 1305456 - 2026-03-03
- FDA Inspection 1117221 - 2020-01-10
- FDA Inspection 906748 - 2014-12-05
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