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657184

Baxter Healthcare Corporation — FEI 1417572

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 29, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Deerfield, IL (United States)

Facility

Other inspections at this facility

  • 1230610 (NAI Tue Feb 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1171501 (VAI Thu Jun 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067768 (NAI Wed Aug 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988263 (VAI Wed Sep 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921291 (NAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
329921 CFR 820.100(a)(1)Procedure for analysis of data sources
330421 CFR 820.100(a)(5)Changes to correct/prevent quality problems
342721 CFR 820.50(a)(2)Supplier oversight
366721 CFR 820.20(c)Management review accomplishment
368721 CFR 820.100(a)(1)Analysis of data sources
369221 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
405921 CFR 820.22Quality Audits - defined intervals