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1167706

Sovereign Pharmaceuticals, LLC — FEI 3003229412

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 22, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Worth, TX (United States)

Facility

Other inspections at this facility

  • 1216978 (OAI Wed Aug 02 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150443 (VAI Wed Sep 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112743 (VAI Thu Dec 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074957 (NAI Wed Dec 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1037483 (VAI Fri Jan 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
357021 CFR 211.100(a)Approval and review of procedures
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed