Home / Inspections / 951391

951391

Nippon Fine Chemical Co., Ltd. — FEI 3001722961

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 17, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Takasago (Japan)

Facility

Other inspections at this facility

  • 1294330 (VAI Fri Nov 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095031 (VAI Tue Jun 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001381 (VAI Tue Jan 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 680721 (VAI Thu Jun 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
143521 CFR 211.42(c)(10)(v)Cleaning System
186921 CFR 211.94(c)Containers & Closures Clean, Sterilized, Pyrogen-free
357721 CFR 211.101(b)(4)Subdivided component/container/finished drug