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Warning Letter

Case 711699 — FEI 3000719870

Facility

Recent inspections

  • 1265697 (OAI Thu Apr 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034994 (VAI Thu Dec 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805646 (VAI Thu Nov 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 699038 (VAI Wed Nov 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 554200 (VAI Tue Dec 30 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Kath Khemicals LLC
Date
September 22, 2025
Fiscal Year
2025
Product Type
Drugs
Center
CDER
Location
Macomb, MI (United States)