1292056

Proxtalker.Com, Llc — FEI 3009444092

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 18, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Waterbury, CT (United States)

Citations

IDCFRDescription
2279521 CFR 801.20(a)Label to bear a unique device identifier
2280021 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
313021 CFR 820.100(a)Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures