FDA Inspection
Institutional Review Board of Swedish Health ServicesInstitutional Review Board of Swedish Health Services – FDA Inspection, Oct 1, 2010
Record Details
This FDA Inspection record concerns Institutional Review Board of Swedish Health Services, with an inspection on October 1, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 1, 2010
- Product Type
- Drugs
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ID · 3ce8c7a9-a582-4e01-b1f2-11dd2b011558
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 683787
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.111(a)(4)Informed consent sought
- 21 CFR 56.111(a)(3)Selection of subjects equitable
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Institutional Review Board of Swedish Health Services
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Institutional Review Board of Swedish Health Services
- FDA Inspection 1063953 - 2018-08-17
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