FDA Inspection
otOregon College Oriental Medicine IRBotOregon College Oriental Medicine IRB – FDA Inspection, Sep 19, 2012
Record Details
This FDA Inspection record concerns otOregon College Oriental Medicine IRB, with an inspection on September 19, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 19, 2012
- Product Type
- Drugs
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ID · 9e02df12-4405-4b70-901d-5b1533e65b7b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 801036
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 50.25(a)(4)Alternate procedures, courses of treatment
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