FDA Inspection
Samuel N. Lederman, M.D.Samuel N. Lederman, M.D. – FDA Inspection, Jun 3, 2013
Record Details
This FDA Inspection record concerns Samuel N. Lederman, M.D., with an inspection on June 3, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Samuel N. Lederman, M.D.
- Inspection Date
- June 3, 2013
- Product Type
- Drugs
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ID · b2fb76e0-606e-4f15-904b-2524c08bad4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838148
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 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 312.66Unanticipated problems
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Other FDA inspections of Samuel N. Lederman, M.D.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 11, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Samuel N. Lederman, M.D.
- FDA Inspection 1210809 - 2023-07-21
- FDA Inspection 1076541 - 2019-01-11
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