FDA Inspection
Prof. Dr. Raimund JakeszProf. Dr. Raimund Jakesz – FDA Inspection, Sep 17, 2010
Record Details
This FDA Inspection record concerns Prof. Dr. Raimund Jakesz, with an inspection on September 17, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Prof. Dr. Raimund Jakesz
- Inspection Date
- September 17, 2010
- Product Type
- Drugs
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ID · f46c173f-a19f-4dcc-a3fe-e393a4a3ebfe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750719
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 312.66Changes in research
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