FDA Inspection
Duke Clinical Research InstituteDuke Clinical Research Institute – FDA Inspection, Nov 4, 2015
Record Details
This FDA Inspection record concerns Duke Clinical Research Institute, with an inspection on November 4, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 4, 2015
- Product Type
- Drugs
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ID · 87959370-6a66-494c-aa9f-39ef92b21d0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953435
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.50Ensuring compliance with plan and protocol
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Other FDA inspections of Duke Clinical Research Institute
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 19, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 24, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Duke Clinical Research Institute
- FDA Inspection 1081929 - 2019-01-17
- FDA Inspection 848158 - 2013-09-19
- FDA Inspection 796022 - 2012-08-24
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