Terumo Medical Products Hangzhou Co., Ltd. - March 21, 2013
Issue Date
Mar 21, 2013
Region
HQ
Category
Device
$117.00
Contact Name
Shibazaki Takanori
Contact Title
Chairman & President
Address 1
M4-9-5 Hangzhou Economic & Technological Development
City
Hangzhou
Zip/Postal Code
310018
Country
China
Inspection Range
Mar 18, 2013 - Mar 21, 2013
Pages
2
First Observation
A 5 day report was not submitted to FDA on Form 3500A within 5 workdays of becoming aware that a reportable MDR event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.
Investigator(s): Minh D. Phan