FDA Inspection
Hurley Medical Center IRBHurley Medical Center IRB – FDA Inspection, Aug 21, 2015
Record Details
This FDA Inspection record concerns Hurley Medical Center IRB, with an inspection on August 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hurley Medical Center IRB
- Inspection Date
- August 21, 2015
- Product Type
- Devices
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ID · bf58b7b8-f143-4250-8d6a-42d0cdc84725
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 941330
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.111(b)Vulnerable subject safeguards
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.113Reporting
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Other FDA inspections of Hurley Medical Center IRB
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 15, 2010 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Hurley Medical Center IRB
- FDA Inspection 1098043 - 2019-07-09
- FDA Inspection 702009 - 2010-12-15
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