Tricol Biomedical, Inc. - April 2, 2018
Issue Date
Apr 02, 2018
Region
Pacific
Category
Device
$117.00
Contact Name
Kz Hong
Contact Title
President and CEO
Address 1
720 S.W. Washington St.
Address 2
Ste. 200
City
Portland
State
OR
Zip/Postal Code
97205
Country
United States
Inspection Range
Mar 26, 2018 - Apr 02, 2018
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): James D. Hildreth