FDA Inspection
Medstar Health Research Institute IRBMedstar Health Research Institute IRB – FDA Inspection, Jan 10, 2018
Record Details
This FDA Inspection record concerns Medstar Health Research Institute IRB, with an inspection on January 10, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d3265320-968e-4ca1-8495-298f9058ea1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037207
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(c)Approval from a majority of members present
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Other FDA inspections of Medstar Health Research Institute IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2023 | NAI | Bioresearch Monitoring | |
| July 2, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Medstar Health Research Institute IRB
- FDA Inspection 1206246 - 2023-05-11
- FDA Inspection 885841 - 2014-07-02
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