Edwards Lifesciences, LLC (NYSE: EW), Draper, UT – FDA Inspections

Inspection records and compliance data for Edwards Lifesciences, LLC in Draper, Utah. 9 FDA inspections on record (2 OAI), last inspected November 19, 2021. Publicly traded as NYSE: EW.

Company Profile

This profile covers Edwards Lifesciences, LLC based in Draper, Utah, United States.

FDA Inspection History

FDA inspections: 9
OAI: 2
VAI: 2
NAI: 4
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected November 20, 2009. Last inspected November 19, 2021.

Most cited issue areas

DHR content1 inspection
Documentation of validated process performance1 inspection
Lack of or inadequate DHR procedures1 inspection

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
November 19, 2021	NAI	Medical Devices & Rad Health · Compliance: Devices	1159431
February 1, 2018	NAI	Medical Devices & Rad Health · Bioresearch Monitoring	1041783
September 29, 2017	Not classified	Medical Devices & Rad Health	1042659
May 20, 2016	VAI	Medical Devices & Rad Health · Compliance: Devices	973557
November 20, 2015	VAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	951141
April 11, 2014	OAI	Medical Devices & Rad Health · Bioresearch Monitoring	874597
February 22, 2013	OAI	Medical Devices & Rad Health · Compliance: Devices	819579
July 13, 2011	NAI	Medical Devices & Rad Health · Compliance: Devices	739236
November 20, 2009	NAI	Medical Devices & Rad Health · Compliance: Devices	634966