Home / Import refusals / AEK-8218885-3/11/1

FDA Import Refusal AEK-8218885-3/11/1 — Janssen Pharmaceuticals, Inc

Janssen Pharmaceuticals, Inc — FEI 2242843

The FDA refused shipment AEK-8218885-3/11/1 from Janssen Pharmaceuticals, Inc (United States) on February 21, 2025. The refused product falls under Drugs and Biologics — USTEKINUMAB. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 21, 2025
Country
United States
Product Category
Drugs and Biologics
Product Code
58MDY27 USTEKINUMAB
Charges
75

Recent inspections

  • 1271223 (NAI Thu Aug 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229931 (VAI Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131617 (NAI Mon Sep 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131381 (NAI Mon Sep 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031605 (NAI Fri Oct 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-8291214-6/11/1 (Fri Mar 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8217128-9/11/1 (Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8225342-6/11/1 (Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8221486-5/11/1 (Tue Mar 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8226782-2/11/1 (Fri Feb 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources