Home / Inspections / 1086054

1086054

ALLERGAN SALES, LLC — FEI 3012867780

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Madison, NJ (United States)

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Facility

Other inspections at this facility

  • 1095822 (NAI Thu Jun 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050385 (VAI Wed May 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 986938 (VAI Thu Sep 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
21352FDCA 505-1(e)(2)(A)Failure to comply with REMS Medication Guide
21360FDCA 505-1(f)(4)Failure to comply with REMS Implementation System