Home / Import refusals / AEK-0957368-3/30002/1

FDA Import Refusal AEK-0957368-3/30002/1 — Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited — FEI 3003157498

The FDA refused shipment AEK-0957368-3/30002/1 from Intas Pharmaceuticals Limited (India) on September 18, 2026. The refused product falls under Drugs and Biologics — FINASTERIDE (INHIBITOR (DECARBOXYLASE)). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 18, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
64UDL06 FINASTERIDE (INHIBITOR (DECARBOXYLASE))
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))
  • 1005711 (VAI Fri Feb 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-9837718-5/50002/1 (Thu Sep 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9837718-5/10002/1 (Thu Sep 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9888971-8/10003/1 (Wed Sep 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9687524-8/10002/1 (Wed Sep 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9615283-8/30002/1 (Tue Aug 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources