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831076

Simtra US LLC — FEI 1000115571

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 10, 2013
Fiscal Year
2013
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))
  • 1019766 (VAI Mon Jul 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
178721 CFR 211.80(a)Procedures To Be in Writing
431721 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)