FDA Inspection
St. Mary's of Michigan Medical Center IRBSt. Mary's of Michigan Medical Center IRB – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns St. Mary's of Michigan Medical Center IRB, with an inspection on December 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 1, 2011
- Product Type
- Devices
View Company Profile
ID · a3d4464a-e7c4-4fb4-a589-d841702673bb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 755315
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
Full citation text and observation details available on the Dashboard.
Other FDA inspections of St. Mary's of Michigan Medical Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St. Mary's of Michigan Medical Center IRB
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.