Dragon Heart Medical, Inc. - July 2, 2021
Issue Date
Jul 02, 2021
Region
Central
Category
Device
$117.00
Contact Name
Jina Yu
Contact Title
President
Address 1
300 W. Lake St.
City
Elmhurst
State
IL
Zip/Postal Code
60126-1516
Country
United States
Inspection Range
Jun 23, 2021 - Jul 02, 2021
Pages
5
First Observation
The design history file does not demonstrate that the design was developed following the approved
design plan and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Amanda Dinaro