CoolSystems - July 1, 2010
Issue Date
Jul 01, 2010
Region
Pacific
Category
Device
$117.00
Address 1
1201 Marina Village Pkwy.
Address 2
Suite 200
City
Alameda
State
CA
Zip/Postal Code
94501
Country
US
Inspection Range
Jun 22, 2010 - Jul 01, 2010
Pages
2
First Observation
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups, and reviews by a designated person was not included in the record.
Investigator(s): Alla Dubrovsky