Roche Molecular Systems, Inc. - October 20, 2009
Issue Date
Oct 21, 2009
Region
Central
Category
Device
$117.00
Address 1
1080 US Hwy 202 South
City
Somerville
State
NJ
Zip/Postal Code
08876-3733
Country
US
Inspection Range
Sep 24, 2009 - Oct 20, 2009
Pages
4
First Observation
Corrective and preventive actions have not been verified or validated to ensure that the action is effective and does not adversely affect the finished device.
Investigator(s): Amy M. Cramer and Kinh Q. Mac