FDA Inspection
Drexinger, Bernard R. , M.D.Drexinger, Bernard R. , M.D. – FDA Inspection, Sep 16, 2009
Record Details
This FDA Inspection record concerns Drexinger, Bernard R. , M.D., with an inspection on September 16, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Drexinger, Bernard R. , M.D.
- Inspection Date
- September 16, 2009
- Product Type
- Drugs
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ID · c3d2af9f-7207-43fe-a295-d00f0135190e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614001
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
9- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.56(b)Shipments after termination of investigator
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.50Ensuring compliance with plan and protocol
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.56(c)IND safety report
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.62(a)Unused drug disposition (investigator)
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