FDA Inspection
Seton Medical Center IRBSeton Medical Center IRB – FDA Inspection, Jan 27, 2014
Record Details
This FDA Inspection record concerns Seton Medical Center IRB, with an inspection on January 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Seton Medical Center IRB
- Inspection Date
- January 27, 2014
- Product Type
- Devices
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ID · 0fb93e62-7f0c-4d5f-baaa-dbb51c410d50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863974
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.108(a)(1)Initial and continuing reviews
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