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FDA Import Refusal 9ES-0028010-5/2/1 — Alkem Laboratories Limited

Alkem Laboratories Limited — FEI 3006370524

The FDA refused shipment 9ES-0028010-5/2/1 from Alkem Laboratories Limited (India) on June 17, 2016. The refused product falls under Drugs and Biologics — FINASTERIDE (INHIBITOR (DECARBOXYLASE)). Cited charges: 118,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 17, 2016
Country
India
Product Category
Drugs and Biologics
Product Code
64UCA06 FINASTERIDE (INHIBITOR (DECARBOXYLASE))
Charges
118,75

Recent inspections

  • 1106347 (NAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1080442 (NAI Fri Jan 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046054 (VAI Tue Mar 27 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989408 (VAI Thu Sep 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854604 (VAI Fri Oct 25 2013 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)
  • 799-5624433-0/11/4 (Fri Feb 21 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)

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