FDA Inspection
William Backus Hospital IrbWilliam Backus Hospital Irb – FDA Inspection, May 19, 2010
Record Details
This FDA Inspection record concerns William Backus Hospital Irb, with an inspection on May 19, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- William Backus Hospital Irb
- Inspection Date
- May 19, 2010
- Product Type
- Devices
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ID · 8b188a4e-3915-4f1d-b0a1-d58e1ba312ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662702
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
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