Home / Import refusals / AEK-9225324-2/30003/1

FDA Import Refusal AEK-9225324-2/30003/1 — Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited — FEI 3003157498

The FDA refused shipment AEK-9225324-2/30003/1 from Intas Pharmaceuticals Limited (India) on December 29, 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
December 29, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61LDC38 CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
Charges
27

Recent inspections

  • 1245599 (NAI Fri Jul 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1098380 (VAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074349 (NAI Fri Dec 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056170 (VAI Fri Jun 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978469 (VAI Fri Jun 17 2016 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