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1025424

Hisamitsu Pharmaceutical Co., Inc. — FEI 1000266995

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 15, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tosu (Japan)

Facility

Other inspections at this facility

  • 1273761 (VAI Fri Jul 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091243 (VAI Fri May 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 877725 (VAI Fri Apr 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 770008 (VAI Fri Feb 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 584600 (NAI Wed Apr 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
200921 CFR 211.188Prepared for each batch, include complete information
354721 CFR 211.46(b)Equipment for Environmental Control
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls