Home / Inspections / 1240475

1240475

Zoe Medical Incorporated — FEI 3003294644

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 31, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Topsfield, MA (United States)

Facility

Other inspections at this facility

  • 1102382 (VAI Fri Sep 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990061 (NAI Wed Oct 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 817988 (VAI Thu Feb 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 657853 (VAI Tue Apr 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
319121 CFR 820.30(g)Design validation - production units
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements