Company
United StatesGold Standard Diagnostics, Davis, CA – FDA Inspections
Inspection records and compliance data for Gold Standard Diagnostics in Davis, California. 4 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected December 05, 2018.
Company Profile
This profile covers Gold Standard Diagnostics based in Davis, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected December 20, 2013. Last inspected December 5, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 5, 2018 | Not classified | Medical Devices & Rad Health | 1096364 |
| September 13, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1025850 |
| November 7, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 903290 |
| December 20, 2013 | OAI | Medical Devices & Rad Health · Compliance: Devices | 859740 |
FDA documents
Warning Letters (1)
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Company Information
Name
Gold Standard Diagnostics
FEI Number
3007208259
Address
2851 Spafford St Ste A, Davis, California 95618, United States
Country
United States
ID: 35a18b61-b8ce-433f-8958-f55c361c2962