Company
United StatesSilk Road Medical Inc, Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Silk Road Medical Inc in Sunnyvale, California. 6 FDA inspections on record, last inspected October 18, 2023.
Company Profile
This profile covers Silk Road Medical Inc based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 1
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected July 11, 2014. Last inspected October 18, 2023.
Most cited issue areas
- Sponsor final report for significant risk study1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 18, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1221393 |
| February 27, 2020 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1119161 |
| October 3, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 995542 |
| June 23, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 980086 |
| April 14, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 923132 |
| July 11, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 886903 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Silk Road Medical Inc
FEI Number
3007215228
Address
1213 Innsbruck Dr, Sunnyvale, California 94089, United States
Country
United States
ID: c2871080-3c3f-48c8-8b25-c4cfc304f47a