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1234100

CareFusion 303, Inc. — FEI 2016493

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 22, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Compliance: Devices
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 893045 (OAI Mon Sep 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
73221 CFR 803.50(a)(2)Individual Report of Malfunction