Home / Import refusals / AEK-8223415-2/11/1

FDA Import Refusal AEK-8223415-2/11/1 — Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation — FEI 2210396

The FDA refused shipment AEK-8223415-2/11/1 from Novartis Pharmaceuticals Corporation (United States) on March 4, 2025. The refused product falls under Drugs and Biologics — SECUKINUMAB. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 4, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58MCP25 SECUKINUMAB
Charges
75

Recent inspections

  • 1276202 (NAI Wed Jun 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1263198 (NAI Mon Mar 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1257911 (NAI Tue Nov 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1248433 (NAI Thu Aug 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230105 (NAI Thu Jun 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • NUV-3849643-9/20002/1 (Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • NUV-3855286-8/90002/1 (Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7462726-4/40001/1 (Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8401476-8/51/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-5735371-0/11/1 (Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources