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FDA Import Refusal AEK-7671930-9/10003/1 — Hetero Labs Ltd. Unit VI

Hetero Labs Ltd. Unit VI — FEI 3008294355

The FDA refused shipment AEK-7671930-9/10003/1 from Hetero Labs Ltd. Unit VI (India) on October 27, 2025. The refused product falls under Drugs and Biologics — LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II). Cited charges: 118,75 This firm has 3 other import refusals on record.

Refusal Details

Date
October 27, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
62ODA41 LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
Charges
118,75

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

  • 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)
  • AEK-5821380-9/11/1 (Wed Apr 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources