Troy Hounshell - March 4, 2022
Issue Date
Mar 04, 2022
Region
Southwest
Category
Device
$117.00
Address 1
5880 University Ave.
Address 2
Mercy One Iowa Heart Center
City
West Des Moines
State
IA
Zip/Postal Code
50266-8209
Country
United States
Inspection Range
Mar 01, 2022 - Mar 04, 2022
Pages
3
First Observation
An investigation was not conducted in accordance with the signed agreement, the investigational plan and applicable FDA regulations.
Investigator(s): Carmen Y. Fisher