Home / Inspections / 812020

812020

CareFusion 303, Inc. — FEI 2016493

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 18, 2012
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1234100 (OAI Wed May 22 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1166360 (NAI Thu Mar 10 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1123377 (OAI Mon Apr 06 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064813 (OAI Thu Sep 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 987844 (NAI Fri Sep 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate