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Warning Letter

Case 716953 — FEI 1000158477

Facility

Recent inspections

  • 1276805 (OAI Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1122817 (VAI Tue Mar 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 926167 (NAI Fri May 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 743248 (NAI Fri Sep 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 655435 (VAI Mon Apr 05 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Chemisphere Corporation
Date
December 15, 2025
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
Saint Louis, MO (United States)