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770008

Hisamitsu Pharmaceutical Co., Inc. — FEI 1000266995

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2012
Fiscal Year
2012
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))
  • 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))
  • 584600 (NAI Wed Apr 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
149621 CFR 211.122(a)Sampling/testing of labeling/packaging materials
180921 CFR 211.160(a)Following/documenting laboratory controls
191421 CFR 211.166(a)Lack of written stability program
241921 CFR 211.198(a)Complaint Handling Procedure
356521 CFR 211.58Buildings not maintained in good state of repair
359121 CFR 211.110(b)In-process materials specifications
363221 CFR 211.170(b)Annual visual exams of drug products