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1021115

Amneal Pharmaceuticals of New York, LLC — FEI 3005263655

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brookhaven, NY (United States)

Facility

Other inspections at this facility

  • 1207398 (NAI Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116040 (NAI Fri Dec 20 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089916 (NAI Thu Apr 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077700 (VAI Wed Jan 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065634 (NAI Tue Jul 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122321 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
358521 CFR 211.110(a)Control procedures to monitor and validate performance