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1273761

Hisamitsu Pharmaceutical Co., Inc. — FEI 1000266995

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 4, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tosu (Japan)

Facility

Other inspections at this facility

  • 1091243 (VAI Fri May 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025424 (VAI Fri Sep 15 2017 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
136121 CFR 211.100(a)Absence of Written Procedures
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls