Erie Medical, division of Ocenco, Inc.- March 11, 2010
Issue Date
Mar 11, 2010
Region
Central
Category
Device
$117.00
Address 1
10225 82nd Ave.
City
Pleasant Prairie
State
WI
Zip/Postal Code
53158-5800
Country
US
Inspection Range
Mar 08, 2010 - Mar 11, 2010
Pages
3
First Observation
Rework of nonconforming product did not include complete retesting and reevaluation to ensure that the reworked product met current approved specifications.
Investigator(s): Michelle J. Glembin and Melissa J. Ireland