Corelink, LLC - November 12, 2010
Issue Date
Nov 12, 2010
Region
Southwest
Category
Device
$117.00
Address 1
10805 Sunset Office Dr.
Address 2
Suite 300
City
St. Louis
State
MO
Zip/Postal Code
63127
Country
US
Inspection Range
Nov 09, 2010 - Nov 12, 2010
Pages
3
First Observation
Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting, life sustaining finished devices or appropriate components have not been adequately established.
Investigator(s): Sherry G. Bous and Kathleen B. Swat