Home / Import refusals / AEK-5798514-3/11/1

FDA Import Refusal AEK-5798514-3/11/1 — Hetero Labs Limited (Unit V)

Hetero Labs Limited (Unit V) — FEI 3008307735

The FDA refused shipment AEK-5798514-3/11/1 from Hetero Labs Limited (Unit V) (India) on October 29, 2024. The refused product falls under Drugs and Biologics — LACOSAMIDE (ANTI-CONVULSANT). Cited charge: 75 This firm has 3 other import refusals on record.

Refusal Details

Date
October 29, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
61MDY47 LACOSAMIDE (ANTI-CONVULSANT)
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-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)
  • 799-8771027-1/11/2 (Fri Dec 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources