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982074

Amneal Pharmaceuticals of New York, LLC — FEI 2434153

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 9, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Hauppauge, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1118990 (NAI Mon Feb 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082937 (VAI Mon Mar 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007417 (VAI Tue Apr 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918318 (NAI Mon Mar 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865012 (VAI Fri Feb 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
683121 CFR 314.80(c)(2)Late submission of quarterly safety reports
683221 CFR 314.80(c)(2)Late submission of annual safety reports
891221 CFR 314.81(b)(2)Timely submission