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1091111

Amneal Pharmaceuticals Pvt. Ltd. — FEI 3008223599

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tal Bavla, Ahmedabad (India)

Facility

Other inspections at this facility

  • 1216256 (NAI Fri Jul 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121776 (NAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067930 (NAI Fri Aug 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031432 (NAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011379 (NAI Wed Apr 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116321 CFR 211.28(b)Habits of good sanitation & health
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications