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Warning Letter

Case 714137 — FEI 3001617666

Facility

Recent inspections

  • 1269710 (OAI Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231036 (NAI Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203170 (NAI Fri Mar 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1179507 (VAI Wed Sep 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098988 (NAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

Action Details

Facility
Apotex Inc.
Date
October 31, 2025
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
Richmond Hill (Canada)