FDA Inspection
Willner, Mark, M.D.Willner, Mark, M.D. – FDA Inspection, Nov 18, 2008
Record Details
This FDA Inspection record concerns Willner, Mark, M.D., with an inspection on November 18, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Willner, Mark, M.D.
- Inspection Date
- November 18, 2008
- Product Type
- Drugs
View Company Profile
ID · fa249a3c-c332-4d34-a1fe-d2bf707addde
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 557285
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Changes in research
- 21 CFR 50.20Circumstances of obtaining consent
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