Home / Import refusals / AEK-7507398-9/40001/1

FDA Import Refusal AEK-7507398-9/40001/1 — Novartis Pharma AG

Novartis Pharma AG — FEI 3002807772

The FDA refused shipment AEK-7507398-9/40001/1 from Novartis Pharma AG (Switzerland) on September 2, 2025. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 2, 2025
Country
Switzerland
Product Category
Drugs and Biologics
Product Code
56BDY03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
118,75

Recent inspections

  • 1180833 (VAI Tue Aug 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099919 (NAI Fri Jul 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1021086 (VAI Thu Jul 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916149 (NAI Wed Jan 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 861652 (NAI Thu Dec 05 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-0005355-2/10002/1 (Mon Mar 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9480606-2/10002/1 (Wed Feb 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9195715-7/30002/1 (Thu Jan 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6397288-2/10002/1 (Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7507398-9/20002/1 (Tue Sep 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources