FDA Inspection
Indiana Orthopaedic Hospital, LLC IRB #1Indiana Orthopaedic Hospital, LLC IRB #1 – FDA Inspection, Feb 13, 2019
Record Details
This FDA Inspection record concerns Indiana Orthopaedic Hospital, LLC IRB #1, with an inspection on February 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b2bfa3d3-09b0-4103-9ab5-c22f49bbdff3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079147
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Indiana Orthopaedic Hospital, LLC IRB #1
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2013 | 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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