FDA Inspection
Indiana Univ Medical Center RDRCIndiana Univ Medical Center RDRC – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Indiana Univ Medical Center RDRC, with an inspection on September 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 12, 2014
- Product Type
- Drugs
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ID · 3d5907db-e8ae-47ef-adfc-2bafebc96ed8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895920
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 361.1(c)(2)Numerical votes not in the minutes of any RDRC meetings
- 21 CFR 361.1(c)(3)FDA research proposals not reported +30 subjects
- 21 CFR 361.1(c)(1)(ii)RDRC not incl trained person to formulate radioactive drugs
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