Home / Import refusals / AEK-5280756-5/11/1

FDA Import Refusal AEK-5280756-5/11/1 — FDC Limited

FDC Limited — FEI 3003204330

The FDA refused shipment AEK-5280756-5/11/1 from FDC Limited (India) on August 8, 2024. The refused product falls under Drugs and Biologics — CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 8, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
61FDA54 CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
Charges
75

Recent inspections

  • 1202011 (NAI Sun Feb 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062631 (VAI Thu Aug 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979497 (VAI Fri Jul 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 880907 (VAI Tue May 06 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 776677 (VAI Tue Feb 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-7904076-0/10003/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8990952-9/22/2 (Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8306670-2/11/1 (Thu Apr 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Human Foods)
  • 799-3786219-2/21/1 (Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-5720553-0/31/1 (Fri Sep 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources