Home / Import refusals / 799-5624433-0/11/4

FDA Import Refusal 799-5624433-0/11/4 — Alkem Laboratories Limited

Alkem Laboratories Limited — FEI 3006370533

The FDA refused shipment 799-5624433-0/11/4 from Alkem Laboratories Limited (India) on February 21, 2025. The refused product falls under Drugs and Biologics — DOMPERIDONE. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 21, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61TDA31 DOMPERIDONE
Charges
75

Recent inspections

  • 1233569 (VAI Wed Mar 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118336 (VAI Fri Feb 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1140381 (VAI Tue Nov 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1089865 (VAI Fri May 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007598 (VAI Fri Mar 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-9186485-8/50003/1 (Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3800935-6/40003/1 (Tue Oct 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • D82-2245271-5/31/1 (Mon Sep 22 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5822275-1/21/1 (Mon Nov 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3249890-3/21/1 (Thu Apr 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources