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1010061

Inopak Ltd — FEI 1000122232

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 24, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ringwood, NJ (United States)

Facility

Other inspections at this facility

  • 1214661 (OAI Thu Aug 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144199 (OAI Fri Jun 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059942 (OAI Fri Jul 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913858 (VAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797562 (VAI Tue Sep 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
16494FDCA 601(c)Insanitary conditions; contaminated with filth
183321 CFR 211.84(d)(1)Identity Testing of Each Component
189021 CFR 211.165(e)Test methods
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
900121 CFR 211.22(a)Lack of quality control unit