Home / Import refusals / AEK-9429853-3/51/1

FDA Import Refusal AEK-9429853-3/51/1 — Accord Healthcare, Inc.

Accord Healthcare, Inc. — FEI 3007518432

The FDA refused shipment AEK-9429853-3/51/1 from Accord Healthcare, Inc. (United States) on July 22, 2021. The refused product falls under Drugs and Biologics — MONTELUKAST SODIUM (ANTI-ASTHMATIC). Cited charges: 118,3280,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 22, 2021
Country
United States
Product Category
Drugs and Biologics
Product Code
61ECA09 MONTELUKAST SODIUM (ANTI-ASTHMATIC)
Charges
118,3280,75

Recent inspections

  • 1005516 (NAI Thu Jan 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859238 (NAI Fri Dec 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 732127 (NAI Wed May 25 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 685512 (VAI Thu Sep 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-9170474-0/30002/1 (Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8532431-5/22/1 (Fri Jun 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0544677-9/11/2 (Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7069429-4/31/1 (Tue Feb 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9429853-3/11/1 (Thu Jul 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources