Copious International, Inc. - Feb. 8, 2018
Issue Date
Feb 08, 2018
Region
HQ
Category
Device
$117.00
Contact Name
Xiaowen Li
Contact Title
Plant Manager
Address 1
Wei 11 Rd., Huada St.
Address 2
New City
City
Heyuan, Guang Dong
Zip/Postal Code
517000
Country
China
Inspection Range
Feb 05, 2018 - Feb 08, 2018
Pages
4
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): Catherine J. Laufmann