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670814

Ipca Laboratories Limited — FEI 3005977675

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 28, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Silvassa (India)

Facility

Other inspections at this facility

  • 1205137 (VAI Wed Apr 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100388 (OAI Fri Aug 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 909724 (OAI Fri Dec 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 792946 (VAI Tue Jul 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
194321 CFR 211.180(e)(1)Review of representative number of batches
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
241921 CFR 211.198(a)Complaint Handling Procedure
256721 CFR 211.198(a)Adverse Drug Experience
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
359121 CFR 211.110(b)In-process materials specifications
360321 CFR 211.160(b)Scientifically sound laboratory controls