FDA Inspection 1197439 — Rigicon AS

Rigicon AS — FEI 3013960851

The FDA completed an inspection of Rigicon AS on February 15, 2023 in Beykoz. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 15, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Beykoz (Turkey)

Citations

IDCFRDescription
369621 CFR 820.100(b)Documentation