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Warning Letter

Case 495946 — FEI 3011286349

Facility

Recent inspections

  • 1230061 (VAI Tue Mar 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1180879 (VAI Fri Sep 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144481 (OAI Tue Jun 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067476 (OAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014041 (OAI Wed May 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

  • Injunction (352) (Mon Dec 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Qualgen, LLC
Date
June 3, 2016
Fiscal Year
2016
Product Type
Drugs
Center
CDER
Location
Edmond, OK (United States)