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913858

Inopak Ltd — FEI 1000122232

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2015
Fiscal Year
2015
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))
  • 1010061 (VAI Fri Mar 24 2017 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
183321 CFR 211.84(d)(1)Identity Testing of Each Component
189021 CFR 211.165(e)Test methods
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance
363021 CFR 211.170(b)Drug product reserve containers
363221 CFR 211.170(b)Annual visual exams of drug products