FDA Inspection
SDI Diagnostics, Inc.SDI Diagnostics, Inc. – FDA Inspection, Sep 30, 2021
Record Details
This FDA Inspection record concerns SDI Diagnostics, Inc., with an inspection on September 30, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SDI Diagnostics, Inc.
- Inspection Date
- September 30, 2021
- Product Type
- Devices
View Company Profile
ID · eb277193-5403-439b-8a1a-212ec8703a95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1153251
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of SDI Diagnostics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SDI Diagnostics, Inc.
- FDA Inspection 847750 - 2013-09-10
- FDA Inspection 726575 - 2011-04-29
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