FDA Inspection 1236857 — Avacen Inc.

Avacen Inc. — FEI 3009668937

The FDA completed an inspection of Avacen Inc. on April 12, 2024 in Carlsbad, CA. 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
April 12, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
Carlsbad, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures