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FDA Import Refusal 110-7960312-2/1/1 — Edwards Lifesciences, LLC

Edwards Lifesciences, LLC — FEI 1713910

The FDA refused shipment 110-7960312-2/1/1 from Edwards Lifesciences, LLC (United States) on April 3, 2002. The refused product falls under Drugs and Biologics — MISCELLANEOUS PATENT MEDICINES, ETC.. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 3, 2002
Country
United States
Product Category
Drugs and Biologics
Product Code
66VIP99 MISCELLANEOUS PATENT MEDICINES, ETC.
Charges
75

Recent inspections

  • 1159431 (NAI Fri Nov 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041783 (NAI Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 973557 (VAI Fri May 20 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951141 (VAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874597 (NAI Fri Apr 11 2014 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