Edwards Lifesciences Technology SARL - Jan. 27, 2015
Issue Date
Jan 27, 2015
Region
Southeast
Category
Device
$117.00
Contact Name
Carlos Rivera Velez
Contact Title
Vice President & General Manager
Address 1
Hwy. #402 N, Km 1.4
Address 2
International Industrial Park
City
Anasco
State
PR
Zip/Postal Code
00610
Country
United States
Inspection Range
Jan 27, 2015 - Jan 27, 2015
Pages
6
First Observation
Procedures for corrective and preventive action have not been adequately established.
Investigator(s): Adaliz Santaliz-Cruz