FDA Inspection 1119161 — Silk Road Medical Inc

Silk Road Medical Inc — FEI 3007215228

The FDA completed an inspection of Silk Road Medical Inc on February 27, 2020 in Sunnyvale, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 27, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Sunnyvale, CA (United States)

Citations

IDCFRDescription
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ