FDA Inspection
Richard P. Junghans, M.D., Ph.DRichard P. Junghans, M.D., Ph.D – FDA Inspection, Apr 16, 2013
Record Details
This FDA Inspection record concerns Richard P. Junghans, M.D., Ph.D, with an inspection on April 16, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 16, 2013
- Product Type
- Biologics
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ID · e6ae17c2-eea5-4db2-a391-138f9cd7acd9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828636
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.56(a)Monitoring investigations
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Consent form not approved/signed/dated
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