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FDA Import Refusal AEK-5821380-9/11/1 — Hetero Labs Ltd. Unit VI

Hetero Labs Ltd. Unit VI — FEI 3008294355

The FDA refused shipment AEK-5821380-9/11/1 from Hetero Labs Ltd. Unit VI (India) on April 24, 2019. The refused product falls under Drugs and Biologics — LAMIVUDINE; ZIDOVUDINE (ANTI-VIRAL). Cited charge: 75 This firm has 3 other import refusals on record.

Refusal Details

Date
April 24, 2019
Country
India
Product Category
Drugs and Biologics
Product Code
62VDY78 LAMIVUDINE; ZIDOVUDINE (ANTI-VIRAL)
Charges
75

Recent inspections

  • 1218220 (VAI Thu Sep 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999209 (OAI Tue Nov 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833134 (VAI Thu May 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-7671930-9/10003/1 (Mon Oct 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5429250-3/11/1 (Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3949418-2/11/1 (Thu Aug 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources