Home / Import refusals / AEK-7457773-3/20002/1

FDA Import Refusal AEK-7457773-3/20002/1 — Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited — FEI 3004011473

The FDA refused shipment AEK-7457773-3/20002/1 from Intas Pharmaceuticals Limited (India) on August 18, 2025. The refused product falls under Drugs and Biologics — CLOPIDOGREL BISULFATE (ANTI-COAGULANT). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 18, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61LDE38 CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
Charges
27

Recent inspections

  • 1191818 (OAI Fri Dec 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119170 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1092798 (VAI Tue May 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992746 (VAI Wed Oct 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 910188 (NAI Fri Dec 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-5380728-4/10002/2 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-2344992-8/20002/2 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-2344992-8/20002/1 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-4495920-2/20002/4 (Wed May 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-4495920-2/20002/1 (Wed May 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources