Home / Import refusals / AEK-7511326-3/21/1

FDA Import Refusal AEK-7511326-3/21/1 — Organon Pharma (UK) Ltd.

Organon Pharma (UK) Ltd. — FEI 3002807653

The FDA refused shipment AEK-7511326-3/21/1 from Organon Pharma (UK) Ltd. (United Kingdom) on June 19, 2020. The refused product falls under Drugs and Biologics — MONTELUKAST SODIUM (ANTI-ASTHMATIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 19, 2020
Country
United Kingdom
Product Category
Drugs and Biologics
Product Code
61ECB09 MONTELUKAST SODIUM (ANTI-ASTHMATIC)
Charges
75

Recent inspections

  • 1273172 (VAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093308 (VAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916040 (NAI Fri Feb 06 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826684 (VAI Fri Mar 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 651971 (NAI Tue Mar 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-5133554-8/40002/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1506888-7/11/1 (Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1469564-7/11/1 (Thu Mar 18 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7723792-0/11/1 (Wed Aug 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2564076-3/31/1 (Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources