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FDA Import Refusal 316-0835844-1/11/1 — Sun Pharmaceutical Industries Limited

Sun Pharmaceutical Industries Limited — FEI 3004561553

The FDA refused shipment 316-0835844-1/11/1 from Sun Pharmaceutical Industries Limited (India) on September 7, 2018. The refused product falls under Drugs and Biologics — BOSENTAN. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 7, 2018
Country
India
Product Category
Drugs and Biologics
Product Code
62CCA66 BOSENTAN
Charges
75

Recent inspections

  • 1084595 (VAI Fri Mar 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012008 (VAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915847 (VAI Fri Jan 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834084 (NAI Fri May 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 738976 (NAI Fri Jun 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-3504794-8/10002/1 (Tue Sep 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2496810-0/21/1 (Tue Jan 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1252035-7/51/1 (Thu Jun 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-4336398-7/11/1 (Wed Mar 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8624684-7/21/1 (Tue Jan 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources