Home / Import refusals / 799-0832331-5/11/1

FDA Import Refusal 799-0832331-5/11/1 — Apotex Inc.

Apotex Inc. — FEI 3002906944

The FDA refused shipment 799-0832331-5/11/1 from Apotex Inc. (Canada) on June 25, 2024. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 25, 2024
Country
Canada
Product Category
Drugs and Biologics
Product Code
56BCA03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
75

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

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