FDA Inspection
Gold Standard DiagnosticsGold Standard Diagnostics – FDA Inspection, Sep 13, 2017
Record Details
This FDA Inspection record concerns Gold Standard Diagnostics, with an inspection on September 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 6dffab00-930e-4a5b-a2e0-3c0890323710
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1025850
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.40Procedures not adequately established or maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gold Standard Diagnostics
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2018 | Not classified | San Francisco District Office | |
| November 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 20, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gold Standard Diagnostics
- FDA Inspection 1096364 - 2018-12-05
- FDA Inspection 903290 - 2014-11-07
- FDA Inspection 859740 - 2013-12-20
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