Cardionet, Inc. - 12/20/2011
Issue Date
Dec 20, 2011
Region
Pacific
Category
Device
$117.00
Address 1
750 B Street
Address 2
Suite 1400
City
San Diego
State
CA
Zip/Postal Code
92101
Country
United States
Inspection Range
Dec 14, 2011 - Dec 20, 2011
Pages
3
First Observation
An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block H whether remedial action was taken and type.
Investigator(s): Katherine E. Jacobitz and Scott K. Zika