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1144199

Inopak Ltd — FEI 1000122232

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 18, 2021
Fiscal Year
2021
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))
  • 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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
136121 CFR 211.100(a)Absence of Written Procedures
139621 CFR 211.42(c)(2)Rejected Material Area
180221 CFR 211.84(b)Representative Samples
180921 CFR 211.160(a)Following/documenting laboratory controls
360321 CFR 211.160(b)Scientifically sound laboratory controls