FDA Inspection
Human Subjects Research CommitteeHuman Subjects Research Committee – FDA Inspection, Aug 23, 2018
Record Details
This FDA Inspection record concerns Human Subjects Research Committee, with an inspection on August 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f9dedc7c-a966-4013-9c76-4fe6d1a38462
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1063044
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.111(a)(4)Informed consent sought
- 21 CFR 56.111(b)Vulnerable subject safeguards
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(b)Research not eligible for expedited review
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Other FDA inspections of Human Subjects Research Committee
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2025 | Not classified | Minneapolis District Office | Bioresearch Monitoring: Human Drugs |
| June 19, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 26, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Human Subjects Research Committee
- FDA Inspection 1279190 - 2025-08-22
- FDA Inspection 885881 - 2014-06-19
- FDA Inspection 829971 - 2013-04-26
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