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1112743

Sovereign Pharmaceuticals, LLC — FEI 3003229412

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 12, 2019
Fiscal Year
2020
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))
  • 1167706 (OAI Fri Apr 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150443 (VAI Wed Sep 01 2021 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
202021 CFR 211.188(b)(8)Labeling Control Records and Label Copies
202721 CFR 211.192Investigations of discrepancies, failures