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1275087

Shionogi Pharma Co., Ltd. — FEI 3002808135

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 1, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Isawa-Gun (Japan)

Facility

Other inspections at this facility

  • 1069417 (NAI Fri Sep 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009607 (NAI Fri Sep 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009606 (VAI Fri Sep 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874759 (VAI Tue Apr 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 772467 (NAI Thu Feb 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products