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Warning Letter

Case 607098 — FEI 1000149906

Facility

Recent inspections

  • 1148897 (VAI Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121267 (OAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030778 (VAI Fri Nov 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 832137 (VAI Fri May 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 631021 (VAI Fri Nov 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Kalchem International, Inc.
Date
August 27, 2020
Fiscal Year
2020
Product Type
Drugs
Center
CDER
Location
Lindsay, OK (United States)