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1075479

Baxter Healthcare Corporation — FEI 2618677

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 21, 2018
Fiscal Year
2019
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))
  • 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))
  • 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
122721 CFR 211.67(c)Cleaning/maintenance records not kept
136121 CFR 211.100(a)Absence of Written Procedures
178721 CFR 211.80(a)Procedures To Be in Writing
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed
191721 CFR 211.166(a)(1)Sample size - test intervals
202721 CFR 211.192Investigations of discrepancies, failures
203421 CFR 211.194(d)Laboratory equipment calibration records
356521 CFR 211.58Buildings not maintained in good state of repair
362921 CFR 211.170(b)Reserve samples identified, representative, stored