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1107699

Sato Pharmaceutical Co., Ltd. — FEI 3004055563

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 25, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hachioji (Japan)

Facility

Other inspections at this facility

  • 1292356 (OAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111704 (NAI Thu Nov 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064716 (VAI Tue Jul 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961508 (OAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 808343 (NAI Fri Nov 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180921 CFR 211.160(a)Following/documenting laboratory controls
201721 CFR 211.188(b)(5)In-Process and Laboratory Control Results
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair
434021 CFR 211.142Written warehousing procedures established/followed
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination