Home / Import refusals / 799-8316376-7/11/2

FDA Import Refusal 799-8316376-7/11/2 — Lupin Ltd.

Lupin Ltd. — FEI 3004995645

The FDA refused shipment 799-8316376-7/11/2 from Lupin Ltd. (India) on December 15, 2023. The refused product falls under Drugs and Biologics — RIFABUTIN (ANTI-INFECTIVE, TOPICAL). Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 15, 2023
Country
India
Product Category
Drugs and Biologics
Product Code
62FCA54 RIFABUTIN (ANTI-INFECTIVE, TOPICAL)
Charges
118,3280

Recent inspections

  • 1235550 (VAI Fri Mar 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121188 (NAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 919852 (VAI Fri Apr 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793847 (NAI Fri Jul 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 636963 (NAI Thu Nov 05 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-0265576-8/10002/1 (Tue May 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0113241-3/10002/1 (Mon Mar 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9455094-2/10003/1 (Tue Mar 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9432979-2/50003/1 (Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9088021-0/10003/1 (Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources