Heartware, Inc. - July 12, 2018
Issue Date
Aug 07, 2018
Region
Southeast
Category
Device
$117.00
Contact Name
Salvador V. Aloma
Contact Title
Senior Manufacturing Director
Address 1
14400 N.W. 60th Ave.
City
Miami Lakes
State
FL
Zip/Postal Code
33014-2807
Country
United States
Inspection Range
May 17, 2018 - Jul 12, 2018
Pages
16
First Observation
Procedures for design control have not been established.
Investigator(s): Dianiris C. Ayala and Karen M. Rodriguez