FDA Inspection
Shirish M. Gadgeel, MDShirish M. Gadgeel, MD – FDA Inspection, Aug 23, 2024
Record Details
This FDA Inspection record concerns Shirish M. Gadgeel, MD, with an inspection on August 23, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c1279f90-646e-4b6d-9d05-86cba2ad67d1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1247253
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60Informed consent
- 21 CFR 312.64(b)Safety Reports - Serious Events
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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Other FDA inspections of Shirish M. Gadgeel, MD
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 3, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Shirish M. Gadgeel, MD
- FDA Inspection 1165397 - 2022-03-14
- FDA Inspection 946360 - 2015-09-03
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