PatCen Healthcare, Inc. - Jan. 14, 2020
Issue Date
Jan 14, 2020
Region
Pacific
Category
Device
$117.00
Contact Name
Sujit S. Kurnan
Contact Title
CEO
Address 1
3600 136th Pl. SE
Address 2
Ste. 300
City
Bellevue
State
WA
Zip/Postal Code
98006-1468
Country
United States
Inspection Range
Jan 13, 2020 - Jan 14, 2020
Pages
3
First Observation
The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to FDA.
Investigator(s): Stephen R. Souza