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1019766

Simtra US LLC — FEI 1000115571

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bloomington, IN (United States)

Facility

Other inspections at this facility

  • 1242468 (VAI Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200813 (NAI Fri Feb 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1157719 (VAI Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060004 (VAI Wed May 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969863 (VAI Thu May 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products