Applied Diabetes Research, Inc. - July 18, 2011
Issue Date
Jul 18, 2011
Region
Southwest
Category
Device
$117.00
Address 1
1420 Valwood Pkwy, Ste. 205
City
Carrollton
State
TX
Zip/Postal Code
75006-8386
Country
US
Inspection Range
Jul 11, 2011 - Jul 15, 2011
Pages
5
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Lauren E. Skokan