FDA Inspection
Exempla Healthcare, IRBExempla Healthcare, IRB – FDA Inspection, Sep 21, 2009
Record Details
This FDA Inspection record concerns Exempla Healthcare, IRB, with an inspection on September 21, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Exempla Healthcare, IRB
- Inspection Date
- September 21, 2009
- Product Type
- Drugs
View Company Profile
ID · d7eae504-3705-43cb-b31a-fe386a18a059
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 617080
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.111(b)Vulnerable subject safeguards
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.108(a)(4)Changes in approved research
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Other FDA inspections of Exempla Healthcare, IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Exempla Healthcare, IRB
- FDA Inspection 864809 - 2014-01-27
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