Home / Import refusals / SCS-1117084-7/102/1

FDA Import Refusal SCS-1117084-7/102/1 — Sun Pharmaceutical Industries Ltd.

Sun Pharmaceutical Industries Ltd. — FEI 3002809586

The FDA refused shipment SCS-1117084-7/102/1 from Sun Pharmaceutical Industries Ltd. (India) on June 11, 2025. The refused product falls under Drugs and Biologics — MONTELUKAST SODIUM (ANTI-ASTHMATIC). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 11, 2025
Country
India
Product Category
Drugs and Biologics
Product Code
61EBY09 MONTELUKAST SODIUM (ANTI-ASTHMATIC)
Charges
27

Recent inspections

  • 1272871 (OAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1169254 (OAI Mon May 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112832 (OAI Fri Dec 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1095656 (NAI Tue Jun 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076538 (NAI Thu Dec 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-0329279-3/50002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-9751970-5/20002/2 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-4495920-2/10002/1 (Wed May 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0196412-0/10002/1 (Mon May 04 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7736330-5/10003/1 (Fri Apr 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources