FDA Inspection
Silk Road Medical IncSilk Road Medical Inc – FDA Inspection, Apr 14, 2015
Record Details
This FDA Inspection record concerns Silk Road Medical Inc, with an inspection on April 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Silk Road Medical Inc
- Inspection Date
- April 14, 2015
- Product Type
- Devices
View Company Profile
ID · 42338d3c-7a52-461c-84f9-ced9fa980f63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 923132
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.150(b)(7)Sponsor final report for significant risk study
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Silk Road Medical Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 27, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 3, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 11, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Silk Road Medical Inc
- FDA Inspection 1221393 - 2023-10-18
- FDA Inspection 1119161 - 2020-02-27
- FDA Inspection 995542 - 2016-10-03
- FDA Inspection 980086 - 2016-06-23
- FDA Inspection 886903 - 2014-07-11
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