FDA Inspection
Raritan Bay Medical Ctr IRBRaritan Bay Medical Ctr IRB – FDA Inspection, May 28, 2015
Record Details
This FDA Inspection record concerns Raritan Bay Medical Ctr IRB, with an inspection on May 28, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Raritan Bay Medical Ctr IRB
- Inspection Date
- May 28, 2015
- Product Type
- Devices
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ID · fe9231a0-eec5-44b4-8879-83dd32334621
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 927710
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.107(a)At least five members with varying backgrounds
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