FDA Inspection
Karen K. Winer, M.D.Karen K. Winer, M.D. – FDA Inspection, Feb 3, 2010
Record Details
This FDA Inspection record concerns Karen K. Winer, M.D., with an inspection on February 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Karen K. Winer, M.D.
- Inspection Date
- February 3, 2010
- Product Type
- Drugs
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ID · 79616f7c-1150-475a-8422-0ec89600ba8a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 646330
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.50Ensuring compliance with plan and protocol
- 21 CFR 312.56(a)Monitoring investigations
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 50.27(a)Consent form not approved/signed/dated
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Other FDA inspections of Karen K. Winer, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Karen K. Winer, M.D.
- FDA Inspection 751446 - 2011-10-26
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