FDA Inspection
Bruce E. Silverstein, M.D.Bruce E. Silverstein, M.D. – FDA Inspection, Dec 9, 2016
Record Details
This FDA Inspection record concerns Bruce E. Silverstein, M.D., with an inspection on December 9, 2016, issued by the San Francisco District Office, covering human drugs.
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ID · aaa375d9-896b-4325-bd2e-7a34dc2c58db
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 994272
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 312.57(a)Records of receipt, shipment, disposition
- 21 CFR 312.57(d)Bioequivalence samples
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(a)Accountability records
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Other FDA inspections of Bruce E. Silverstein, M.D.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 25, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 4, 2009 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Bruce E. Silverstein, M.D.
- FDA Inspection 1247752 - 2024-08-09
- FDA Inspection 960549 - 2016-02-25
- FDA Inspection 626582 - 2009-11-04
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