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FDA Import Refusal AEK-7507398-9/20002/1 — Novartis Pharma AG

Novartis Pharma AG — FEI 3002807772

The FDA refused shipment AEK-7507398-9/20002/1 from Novartis Pharma AG (Switzerland) on September 2, 2025. The refused product falls under Drugs and Biologics — DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY). 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
62GDY90 DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
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-7507398-9/40001/1 (Tue Sep 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources