FDA Inspection
Gold Standard DiagnosticsGold Standard Diagnostics – FDA Inspection, Dec 20, 2013
Record Details
This FDA Inspection record concerns Gold Standard Diagnostics, with an inspection on December 20, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gold Standard Diagnostics
- Inspection Date
- December 20, 2013
- Product Type
- Devices
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ID · 82da1995-d625-4bd2-8cc0-d71eb39a262e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 859740
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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 | |
| September 13, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Gold Standard Diagnostics
- FDA Inspection 1096364 - 2018-12-05
- FDA Inspection 1025850 - 2017-09-13
- FDA Inspection 903290 - 2014-11-07
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