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685736

CareFusion 303, Inc. — FEI 2016493

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 8, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: 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
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
367721 CFR 820.30(g)Design validation - software validation not performed
81221 CFR 803.56Submission of Supplement to Individual Report Within One Month