FDA Inspection
Swedish Covenant Hospital IRBSwedish Covenant Hospital IRB – FDA Inspection, Sep 11, 2012
Record Details
This FDA Inspection record concerns Swedish Covenant Hospital IRB, with an inspection on September 11, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 11, 2012
- Product Type
- Devices
View Company Profile
ID · b682c03b-d35c-4bd8-bdb9-b947a87326fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796549
- 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 56.108(a)(1)Initial and continuing reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Swedish Covenant Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 5, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Swedish Covenant Hospital IRB
- FDA Inspection 1059299 - 2018-07-05
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.