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1046054

Alkem Laboratories Limited — FEI 3006370524

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 27, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Daman (India)

Facility

Other inspections at this facility

  • 1106347 (NAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080442 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989408 (VAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854604 (VAI Fri Oct 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 761720 (VAI Fri Dec 09 2011 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
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
180921 CFR 211.160(a)Following/documenting laboratory controls
191221 CFR 211.166(a)Written program not followed
203121 CFR 211.194(a)Complete test data included in records
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
358221 CFR 211.105(a)Identification of containers, lines, equipment
358621 CFR 211.110(a)(1)Tablet or capsule weight variation
360321 CFR 211.160(b)Scientifically sound laboratory controls
436421 CFR 211.176Failing to test for penicillin cross-contamination
900121 CFR 211.22(a)Lack of quality control unit