Home / Inspections / 1084607

1084607

St. Jude Medical, Atrial Fibrillation Division, Inc. — FEI 1000139754

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Saint Paul, MN (United States)

Facility

Other inspections at this facility

  • 1053126 (NAI Thu May 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029059 (NAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
243021 CFR 820.30(b)Design plans - Lack of or inadequate
367421 CFR 820.30(d)Design output - documentation