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925338

Baxter Healthcare Corporation — FEI 2618677

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 1, 2015
Fiscal Year
2015
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))
  • 864714 (OAI Tue Feb 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
180121 CFR 211.84(a)Components withheld from use pending release
186821 CFR 211.94(b)Protection from external factors
202721 CFR 211.192Investigations of discrepancies, failures
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