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961508

Sato Pharmaceutical Co., Ltd. — FEI 3004055563

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 12, 2016
Fiscal Year
2016
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))
  • 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))
  • 808343 (NAI Fri Nov 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145221 CFR 211.113(b)Validation lacking for sterile drug products
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
203321 CFR 211.194(c)Testing and standardization of standards et. al.
239921 CFR 211.194(a)(2)Laboratory Test Method Verification