Home / Import refusals / 8NP-0055905-8/11/1

FDA Import Refusal 8NP-0055905-8/11/1 — Janssen Biologics B.V.

Janssen Biologics B.V. — FEI 3002806632

The FDA refused shipment 8NP-0055905-8/11/1 from Janssen Biologics B.V. (Netherlands) on April 19, 2021. The refused product falls under Drugs and Biologics — USTEKINUMAB (ANTI-PSORIATIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 19, 2021
Country
Netherlands
Product Category
Drugs and Biologics
Product Code
62NAA09 USTEKINUMAB (ANTI-PSORIATIC)
Charges
75

Recent inspections

  • 1272273 (VAI Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1126291 (VAI Thu Oct 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076442 (NAI Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975458 (NAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891657 (VAI Fri Jul 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-0489887-9/10002/1 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0149781-6/10002/1 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7490829-7/10002/1 (Mon Nov 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5453929-9/11/1 (Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5453860-6/11/1 (Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources