FDA Inspection
St Lukes Health System IRBSt Lukes Health System IRB – FDA Inspection, Mar 27, 2013
Record Details
This FDA Inspection record concerns St Lukes Health System IRB, with an inspection on March 27, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- St Lukes Health System IRB
- Inspection Date
- March 27, 2013
- Product Type
- Biologics
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ID · 8da422ea-922d-44b8-b27e-5795ac02b0ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 827428
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 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)Initial and continuing reviews
- 21 CFR 56.110(b)(2)Minor changes
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Other FDA inspections of St Lukes Health System IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for St Lukes Health System IRB
- FDA Inspection 1088253 - 2019-04-18
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