Home / Inspections / 1289008

1289008

Allwell Medical Corporation — FEI 3007138831

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Raleigh, NC (United States)

Facility

Other inspections at this facility

  • 1095016 (VAI Tue Jul 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890938 (NAI Wed Jul 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736566 (VAI Wed Jul 20 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events