FDA Inspection
Hurley Medical Center IRBHurley Medical Center IRB – FDA Inspection, Dec 15, 2010
Record Details
This FDA Inspection record concerns Hurley Medical Center IRB, with an inspection on December 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hurley Medical Center IRB
- Inspection Date
- December 15, 2010
- Product Type
- Drugs
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ID · 6f19193a-44c4-41e2-bdbe-4f27050b4340
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 702009
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.109(h)Children as subjects
- 21 CFR 56.109(f)Continuing review
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
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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 |
| August 21, 2015 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Hurley Medical Center IRB
- FDA Inspection 1098043 - 2019-07-09
- FDA Inspection 941330 - 2015-08-21
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