Home / Import refusals / AEK-5093489-0/11/1

FDA Import Refusal AEK-5093489-0/11/1 — Apotex Inc.

Apotex Inc. — FEI 3000114091

The FDA refused shipment AEK-5093489-0/11/1 from Apotex Inc. (Canada) on August 8, 2024. The refused product falls under Drugs and Biologics — ALENDRONATE SODIUM (BONE CALCIUM REGULATOR). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 8, 2024
Country
Canada
Product Category
Drugs and Biologics
Product Code
63ACY02 ALENDRONATE SODIUM (BONE CALCIUM REGULATOR)
Charges
75

Recent inspections

  • 1269863 (VAI Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194792 (VAI Fri Dec 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095165 (NAI Fri May 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002803 (VAI Fri Dec 02 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 905258 (VAI Fri Nov 21 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-3885306-2/10002/1 (Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1232019-2/20003/1 (Tue Dec 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5212840-5/10003/1 (Mon Oct 20 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)

FDA data resources