FDA Inspection
The Burke Rehabilitation Hospital (IRB)The Burke Rehabilitation Hospital (IRB) – FDA Inspection, Jun 2, 2009
Record Details
This FDA Inspection record concerns The Burke Rehabilitation Hospital (IRB), with an inspection on June 2, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 2, 2009
- Product Type
- Drugs
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ID · df5d18b3-7858-445a-a6ac-95600c74ffea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 581221
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
7- 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)(2)Minutes of IRB meetings
- 21 CFR 50.20Exculpatory language, waiving of rights
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
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