FDA Inspection
Lakeland Hospitals Niles And St. Joseph IRBLakeland Hospitals Niles And St. Joseph IRB – FDA Inspection, Oct 27, 2011
Record Details
This FDA Inspection record concerns Lakeland Hospitals Niles And St. Joseph IRB, with an inspection on October 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 27, 2011
- Product Type
- Devices
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ID · 45202442-064a-4b88-93df-4538265ff26f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 751443
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Lakeland Hospitals Niles And St. Joseph IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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