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1243288

Unichem Laboratories Limited — FEI 3005497507

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 15, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pilerne Bardez (India)

Facility

Other inspections at this facility

  • 1159456 (VAI Sun Jan 12 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102049 (VAI Wed Jul 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922923 (VAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777002 (VAI Fri Apr 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 591445 (VAI Fri May 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
202721 CFR 211.192Investigations of discrepancies, failures
900121 CFR 211.22(a)Lack of quality control unit