Home / Import refusals / AEK-9615283-8/30002/1

FDA Import Refusal AEK-9615283-8/30002/1 — Intas Pharmaceuticals Limited

Intas Pharmaceuticals Limited — FEI 3004011473

The FDA refused shipment AEK-9615283-8/30002/1 from Intas Pharmaceuticals Limited (India) on August 25, 2026. The refused product falls under Drugs and Biologics — MIRTAZAPINE (ANTI-DEPRESSANT). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 25, 2026
Country
India
Product Category
Drugs and Biologics
Product Code
61NDA73 MIRTAZAPINE (ANTI-DEPRESSANT)
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

  • 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-0957368-3/30002/1 (Fri Sep 18 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)

FDA data resources