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FDA Import Refusal AQK-0001189-0/1/2 — Edwards Lifesciences, LLC

Edwards Lifesciences, LLC — FEI 2015691

The FDA refused shipment AQK-0001189-0/1/2 from Edwards Lifesciences, LLC (United States) on May 17, 2005. The refused product falls under Devices — CATHETER, INFUSION, SYRINGE. Cited charges: 118,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 17, 2005
Country
United States
Product Category
Devices
Product Code
74NPG CATHETER, INFUSION, SYRINGE
Charges
118,341

Recent inspections

  • 1229680 (NAI Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194166 (NAI Tue Dec 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100450 (NAI Mon Aug 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093187 (VAI Fri Jun 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959741 (NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 101-8366633-8/231/1 (Thu Oct 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/71/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/121/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/181/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 101-8218276-6/61/1 (Wed Nov 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources