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845707

ImprimisRx NJ LLC — FEI 3003348498

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 19, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ledgewood, NJ (United States)

Facility

Other inspections at this facility

  • 1177284 (OAI Fri Aug 05 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087778 (VAI Tue Apr 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027726 (VAI Mon Jul 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945463 (VAI Wed Sep 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886479 (VAI Wed Jul 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
186921 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
192621 CFR 211.166(b)Adequate number of batches on stability
193221 CFR 211.167(a)Sterility/pyrogen-free testing