Home / Import refusals / 112-0111611-3/1/2

FDA Import Refusal 112-0111611-3/1/2 — Ardena U.S. LLC

Ardena U.S. LLC — FEI 3003563645

The FDA refused shipment 112-0111611-3/1/2 from Ardena U.S. LLC (United States) on March 21, 2017. The refused product falls under Devices — OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL. Cited charge: 72 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 21, 2017
Country
United States
Product Category
Devices
Product Code
68XCA99 OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL
Charges
72

Recent inspections

  • 1285382 (NAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1199635 (NAI Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063006 (NAI Fri Jul 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039238 (NAI Fri Jan 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989308 (NAI Mon Oct 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 112-0111611-3/1/1 (Tue Mar 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0193504-1/1/1 (Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9837194-3/1/1 (Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0168724-6/1/2 (Thu May 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0168724-6/1/1 (Thu May 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources