R2 Technology Inc., A Hologic Company - November 17, 2010`
Issue Date
Nov 17, 2010
Region
Pacific
Category
Device
$117.00
Address 1
2585 Augustine Dr.
City
Santa Clara
State
CA
Zip/Postal Code
95404-3003
Country
US
Inspection Range
Nov 09, 2010 - Nov 17, 2010
Pages
3
First Observation
The written MDR procedure does not include an internal system which provides for a standardized review process/procedure for determining when an event meets the criteria for reporting.
Investigator(s): Randall F. Albright, Mary R. Hole, Christine M. Parmentier, and Seema S. Singh