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1089865

Alkem Laboratories Limited — FEI 3006370533

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 17, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tehsil Nalagarh, Baddi (India)

Facility

Other inspections at this facility

  • 1233569 (VAI Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118336 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1140381 (VAI Tue Nov 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007598 (VAI Fri Mar 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939486 (VAI Fri Jul 31 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
110521 CFR 211.22(d)Procedures not in writing, fully followed
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360721 CFR 211.160(b)(2)Acceptance of in-process materials