FDA Inspection
Indiana Orthopaedic Hospital, LLC IRB #1Indiana Orthopaedic Hospital, LLC IRB #1 – FDA Inspection, May 24, 2013
Record Details
This FDA Inspection record concerns Indiana Orthopaedic Hospital, LLC IRB #1, with an inspection on May 24, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 24, 2013
- Product Type
- Devices
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ID · 7805f412-a346-4b79-94f7-7379a83c2c75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 833682
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of Indiana Orthopaedic Hospital, LLC IRB #1
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2019 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 27, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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