Edwards Lifesciences, LLC - April 15, 2014
Issue Date
Apr 15, 2014
Region
Southwest
Category
Device
$117.00
Contact Name
Paul R. Lunsford
Contact Title
Corporate Vice President and General Manager
Address 1
12050 Lone Peak Pkwy.
City
Draper
State
UT
Zip/Postal Code
84020-9414
Country
United States
Inspection Range
Mar 03, 2014 - Apr 11, 2014
Pages
20
First Observation
A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
Investigator(s): Sean T. Creighton, James R. Montero, Janet Pulver, and Amanda S. Zorn