Home / Inspections / 973194

973194

Chartwell Pharmaceuticals West Caldwell LLC — FEI 3005376609

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 25, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
West Caldwell, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1030229 (NAI Mon Sep 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847035 (NAI Fri Sep 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 740705 (VAI Wed Sep 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
683321 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report