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1220156

Panacea Biotec Pharma Limited — FEI 3007187282

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 12, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Solan (India)

Facility

Other inspections at this facility

  • 1172929 (OAI Wed Jun 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093361 (NAI Tue Apr 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1035804 (VAI Wed Dec 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 954394 (VAI Fri Dec 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 852630 (VAI Fri Oct 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
117721 CFR 211.63Equipment Design, Size and Location
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls