FDA Inspection
SDI Diagnostics, Inc.SDI Diagnostics, Inc. – FDA Inspection, Apr 29, 2011
Record Details
This FDA Inspection record concerns SDI Diagnostics, Inc., with an inspection on April 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SDI Diagnostics, Inc.
- Inspection Date
- April 29, 2011
- Product Type
- Devices
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ID · f55282c0-10a3-4acb-941d-0d92ffd5ffde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 726575
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.140Lack of or inadequate procedures for handling
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of SDI Diagnostics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 30, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SDI Diagnostics, Inc.
- FDA Inspection 1153251 - 2021-09-30
- FDA Inspection 847750 - 2013-09-10
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