FDA Inspection
EMH Regional Medical Center IRBEMH Regional Medical Center IRB – FDA Inspection, Oct 29, 2010
Record Details
This FDA Inspection record concerns EMH Regional Medical Center IRB, with an inspection on October 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 29, 2010
- Product Type
- Devices
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ID · 33b00e26-9d96-4879-a00e-714792543521
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695911
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
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Other FDA inspections of EMH Regional Medical Center IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for EMH Regional Medical Center IRB
- FDA Inspection 833420 - 2013-05-17
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