1276334

VASTMED LLC — FEI 3015045320

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 23, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Grand Prairie, TX (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.
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures