FDA Inspection
Inland Institute of Aesthetic Dentistry IRBInland Institute of Aesthetic Dentistry IRB – FDA Inspection, Oct 16, 2014
Record Details
This FDA Inspection record concerns Inland Institute of Aesthetic Dentistry IRB, with an inspection on October 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 16, 2014
- Product Type
- Devices
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ID · 266dce89-126f-4e3a-a4c6-e0bda567befa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 898990
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
17- 21 CFR 50.25(a)(3)Benefits to the subject
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
- 21 CFR 50.25(a)(6)Compensation, medical treatment in event of injury
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 50.25(a)(8)Participation; refusal and discontinuance
- 21 CFR 50.25(a)(1)Statement of research, purpose, duration of participation
- 21 CFR 50.25(b)(1)Statement of risks
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
- 21 CFR 50.25(b)(2)Termination by investigator
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