FDA Inspection
Michael S. Hisey, M.D.Michael S. Hisey, M.D. – FDA Inspection, Sep 8, 2014
Record Details
This FDA Inspection record concerns Michael S. Hisey, M.D., with an inspection on September 8, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Michael S. Hisey, M.D.
- Inspection Date
- September 8, 2014
- Product Type
- Devices
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ID · f9a67c26-b417-48cb-8d07-49ba233a46c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894372
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.140(a)(4)Investigator protocol records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
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Other FDA inspections of Michael S. Hisey, M.D.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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