1279531

Activbody, Inc. — FEI 3015316271

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 22, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
San Diego, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
2280121 CFR 830.310(b)GUDID Information required for unique device identification.
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures