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FDA Import Refusal 799-8771027-1/11/2 — Hetero Labs Limited (Unit V)

Hetero Labs Limited (Unit V) — FEI 3008307735

The FDA refused shipment 799-8771027-1/11/2 from Hetero Labs Limited (Unit V) (India) on December 7, 2018. The refused product falls under Drugs and Biologics — EFAVIRENZ (ANTI-VIRAL). Cited charge: 75 This firm has 3 other import refusals on record.

Refusal Details

Date
December 7, 2018
Country
India
Product Category
Drugs and Biologics
Product Code
62VDY24 EFAVIRENZ (ANTI-VIRAL)
Charges
75

Recent inspections

  • 1178448 (VAI Fri Aug 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995278 (OAI Fri Dec 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928952 (NAI Fri May 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837768 (VAI Fri May 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 700764 (NAI Fri Nov 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-5798514-3/11/1 (Tue Oct 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4013386-8/11/1 (Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 147-0170496-8/11/1 (Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources