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1178952

Cipla Limited — FEI 3004081307

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 26, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Salcette (India)

Facility

Other inspections at this facility

  • 1240813 (VAI Fri Jun 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103305 (OAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078911 (VAI Mon Jan 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1069950 (VAI Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015874 (NAI Fri Jun 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121921 CFR 211.67(b)(2)Cleaning SOPs/schedules
126321 CFR 211.68(b)Computer control of master formula records
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products