FDA Inspection
Pacific University Institutional Review BoardPacific University Institutional Review Board – FDA Inspection, May 18, 2012
Record Details
This FDA Inspection record concerns Pacific University Institutional Review Board, with an inspection on May 18, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 18, 2012
- Product Type
- Devices
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ID · 3b43574f-b9ce-43ff-934a-6a63c1f6bc2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 782433
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 50.25(a)(7)Whom to contact
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(3)Reporting of suspension/termination
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(c)Method to keep members advised
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
- 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records
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