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940328

Kindeva Drug Delivery L.P. — FEI 2010441

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 1, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Northridge, CA (United States)

Facility

Other inspections at this facility

  • 1286864 (VAI Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151074 (NAI Wed Jul 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1082205 (NAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077108 (VAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008836 (VAI Mon Mar 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
194321 CFR 211.180(e)(1)Review of representative number of batches
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls