FDA Inspection
Howard M. Gross, M.D.Howard M. Gross, M.D. – FDA Inspection, Jan 14, 2015
Record Details
This FDA Inspection record concerns Howard M. Gross, M.D., with an inspection on January 14, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Howard M. Gross, M.D.
- Inspection Date
- January 14, 2015
- Product Type
- Drugs
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ID · 6f69de1d-dde8-4647-90b9-6baac0e25406
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 908669
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 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
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Other FDA inspections of Howard M. Gross, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Howard M. Gross, M.D.
- FDA Inspection 979017 - 2016-08-04
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