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FDA Inspection 1216978 — Sovereign Pharmaceuticals, LLC

Sovereign Pharmaceuticals, LLC — FEI 3003229412

The FDA completed an inspection of Sovereign Pharmaceuticals, LLC on August 2, 2023 in Fort Worth, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Drugs.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 2, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Worth, TX (United States)

Facility

Other inspections at this facility

  • 1263602 (VAI Mon May 12 2025 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))
  • 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))

Recent compliance actions

FDA data resources