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877725

Hisamitsu Pharmaceutical Co., Inc. — FEI 1000266995

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 11, 2014
Fiscal Year
2014
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
138821 CFR 211.101(d)Component addition checked by 2nd person
197521 CFR 211.182Written records kept in individual logs
200721 CFR 211.186(a)Signature and checking of records -- 2 persons
437721 CFR 211.188(b)(3)Identification of each component or in-process material