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Warning Letter

Case 680264 — FEI 1720129

Facility

Recent inspections

  • 1231534 (OAI Fri Mar 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1174263 (VAI Mon Jul 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1036150 (VAI Mon Dec 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015917 (VAI Wed May 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 650470 (NAI Thu Mar 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
Optikem International, Inc.
Date
June 20, 2024
Fiscal Year
2024
Product Type
Drugs
Center
CDER
Location
Denver, CO (United States)