FDA Inspection
Lutheran Hospital IRBLutheran Hospital IRB – FDA Inspection, May 10, 2013
Record Details
This FDA Inspection record concerns Lutheran Hospital IRB, with an inspection on May 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Lutheran Hospital IRB
- Inspection Date
- May 10, 2013
- Product Type
- Devices
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ID · 70bafa35-c49c-415a-ad01-0be4c70b1459
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 834002
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.52Factors required for approval
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Other FDA inspections of Lutheran Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2010 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Lutheran Hospital IRB
- FDA Inspection 649224 - 2010-02-23
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