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945463

ImprimisRx NJ LLC — FEI 3003348498

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 30, 2015
Fiscal Year
2015
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))
  • 886479 (VAI Wed Jul 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 845707 (OAI Mon Aug 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
192621 CFR 211.166(b)Adequate number of batches on stability