Home / Import refusals / AEK-1363941-2/11/1

FDA Import Refusal AEK-1363941-2/11/1 — Janssen Pharmaceutica, N.V.

Janssen Pharmaceutica, N.V. — FEI 3002807336

The FDA refused shipment AEK-1363941-2/11/1 from Janssen Pharmaceutica, N.V. (Belgium) on July 26, 2022. The refused product falls under Drugs and Biologics — PALIPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 26, 2022
Country
Belgium
Product Category
Drugs and Biologics
Product Code
66NDY10 PALIPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
Charges
75

Recent inspections

  • 1290376 (NAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1270321 (VAI Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1296030 (VAI Mon May 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203728 (VAI Fri Jul 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055920 (VAI Tue Jun 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 605-1191111-1/20002/1 (Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 605-1191111-1/10002/1 (Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0926189-6/10002/1 (Tue Nov 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5633407-9/11/1 (Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • BNI-0099059-6/61/1F (Fri Apr 29 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources