Ohio Medical Corp. - June 14, 2010
Issue Date
Jun 14, 2010
Region
Central
Category
Device
$117.00
Address 1
1111 Lakeside Dr.
City
Gurnee
State
IL
Zip/Postal Code
60031
Country
US
Inspection Range
Apr 28, 2010 - Jun 14, 2010
Pages
9
First Observation
Corrective and preventive action activities and/or results have not been adequately documented.
Specifically, there is incomplete documentation of CAPA activities to support that a full investigation was conducted and all effectiveness activities were completed.
Investigator(s): Paola S. Barnett and James W. PlucinskiSpecifically, there is incomplete documentation of CAPA activities to support that a full investigation was conducted and all effectiveness activities were completed.