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Import refusals
/ 799-5212840-5/10003/1
799-5212840-5/10003/1
Apotex Inc. — FEI 3002906944
Recent inspections
1269753
(NAI Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
1187415
(NAI Fri Sep 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
1096465
(NAI Wed Jun 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
1055197
(NAI Thu May 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
1014399
(VAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
Compliance actions
Warning Letter (101627)
(Mon Mar 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
Other import refusals
799-1232019-2/20003/1
(Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
799-5212840-5/20003/1
(Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
799-9760033-4/31/2
(Thu Jul 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
AEK-5679307-6/21/1
(Fri Sep 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
799-2871826-2/11/2
(Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
Refusal Details
Date
October 20, 2025
Country
Canada
Product Category
Drugs and Biologics
Product Code
61NDA66 FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
Charges
75