FDA Inspection 1195638 — Avantec Vascular Corporation

Avantec Vascular Corporation — FEI 3003524171

The FDA completed an inspection of Avantec Vascular Corporation on January 26, 2023 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
January 26, 2023
Fiscal Year
2023
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