FDA Inspection
Roshni Kulkarni, MDRoshni Kulkarni, MD – FDA Inspection, Apr 28, 2016
Record Details
This FDA Inspection record concerns Roshni Kulkarni, MD, with an inspection on April 28, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Roshni Kulkarni, MD
- Inspection Date
- April 28, 2016
- Product Type
- Biologics
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ID · cfe8faed-5973-4cad-a812-01e9fac6a244
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 971017
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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Other FDA inspections of Roshni Kulkarni, MD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2022 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| July 9, 2013 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for Roshni Kulkarni, MD
- FDA Inspection 1191749 - 2022-11-18
- FDA Inspection 839533 - 2013-07-09
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