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1009809

Otsuka ICU Medical LLC — FEI 1628454

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 10, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Austin, TX (United States)

Facility

Other inspections at this facility

  • 1243793 (NAI Fri Jun 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880543 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 796073 (VAI Fri Aug 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723658 (OAI Wed Apr 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 633621 (NAI Fri Dec 11 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
189021 CFR 211.165(e)Test methods
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed