FDA Inspection
Helen Mintz-Hittner, M.D.Helen Mintz-Hittner, M.D. – FDA Inspection, Oct 14, 2009
Record Details
This FDA Inspection record concerns Helen Mintz-Hittner, M.D., with an inspection on October 14, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Helen Mintz-Hittner, M.D.
- Inspection Date
- October 14, 2009
- Product Type
- Drugs
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ID · d8bb81c8-149a-455f-8eb5-13a99c8db5f0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 621582
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.66Initial and continuing review
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 50.20Understandable language
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Other FDA inspections of Helen Mintz-Hittner, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2010 | OAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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