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880543

Otsuka ICU Medical LLC — FEI 1628454

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 23, 2014
Fiscal Year
2014
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))
  • 1009809 (VAI Fri Mar 10 2017 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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
145121 CFR 211.113(b)Procedures for sterile drug products
180221 CFR 211.84(b)Representative Samples
184521 CFR 211.84(d)(3)Container/Closure Written Test Procedure
191221 CFR 211.166(a)Written program not followed
200321 CFR 211.184(c)Individual inventory record
202721 CFR 211.192Investigations of discrepancies, failures
358121 CFR 211.101(d)Verification of component addition
361421 CFR 211.160(b)(4)Written calibration procedures
362921 CFR 211.170(b)Reserve samples identified, representative, stored
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
438921 CFR 211.198(a)Procedures to be written and followed