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1272611

Hisamitsu Pharmaceutical Co., Inc. — FEI 3008742780

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 11, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Utsunomiya (Japan)

Facility

Other inspections at this facility

  • 1106332 (VAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006661 (VAI Fri Jan 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
203321 CFR 211.194(c)Testing and standardization of standards et. al.
360321 CFR 211.160(b)Scientifically sound laboratory controls