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864714

Baxter Healthcare Corporation — FEI 2618677

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 11, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Jayuya, PR (United States)

Facility

Other inspections at this facility

  • 1240745 (VAI Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1149615 (NAI Fri Jul 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1075479 (VAI Fri Dec 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 985599 (OAI Mon Oct 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 925338 (OAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
180121 CFR 211.84(a)Components withheld from use pending release
358521 CFR 211.110(a)Control procedures to monitor and validate performance
890721 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration