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1292356

Sato Pharmaceutical Co., Ltd. — FEI 3004055563

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 21, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hachioji (Japan)

Facility

Other inspections at this facility

  • 1111704 (NAI Thu Nov 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107699 (VAI Fri Oct 25 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
104921 CFR 211.22(a)Approve or reject components, products
116221 CFR 211.28(a)Protective Apparel Not Worn
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls