Home / Inspections / 1177284

1177284

ImprimisRx NJ LLC — FEI 3003348498

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 5, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ledgewood, NJ (United States)

Facility

Other inspections at this facility

  • 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))
  • 845707 (OAI Mon Aug 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18936FDCA 501(a)(2)(A)Non-microbial contamination, production area
18942FDCA 501(a)(2)(A)Personnel habits, contamination
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18957FDCA 501(a)(2)(A)Dust-collecting overhangs, surrounding area of ISO 5
18961FDCA 501(a)(2)(A)Air flow quality, higher classified area
18972FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area
18973FDCA 501(a)(2)(A)Disinfecting materials, aseptic processing area