FDA Inspection
Kassa Darge, M.D.Kassa Darge, M.D. – FDA Inspection, May 5, 2016
Record Details
This FDA Inspection record concerns Kassa Darge, M.D., with an inspection on May 5, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kassa Darge, M.D.
- Inspection Date
- May 5, 2016
- Product Type
- Drugs
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ID · a40e28f8-d742-465b-933f-77c5cc33684d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 972690
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.61Unauthorized recipients (investigator)
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.55(e)(2)Two parents" permission: studies under Parts 50.53 - 50.54
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Other FDA inspections of Kassa Darge, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 1, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Kassa Darge, M.D.
- FDA Inspection 972663 - 2016-03-01
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