FDA Inspection
Sterling Diagnostics, Inc.Sterling Diagnostics, Inc. – FDA Inspection, Dec 20, 2017
Record Details
This FDA Inspection record concerns Sterling Diagnostics, Inc., with an inspection on December 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a1f0e2fe-bf3e-4677-bbdf-4a6ef8cd43ed
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1035513
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.75(a)Lack of or inadequate process validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sterling Diagnostics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 13, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterling Diagnostics, Inc.
- FDA Inspection 980678 - 2016-07-28
- FDA Inspection 859085 - 2013-12-16
- FDA Inspection 676805 - 2010-08-13
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