Prodigy Diabetes Care, LLC - April 16, 2012
Issue Date
Apr 16, 2012
Region
Southeast
Category
Device
$117.00
Address 1
9300 Harris Corners Pkwy
Address 2
Ste. 450
City
Charlotte
State
NC
Zip/Postal Code
28269
Country
US
Inspection Range
Mar 05, 2012 - Apr 16, 2012
Pages
7
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): E. Harold Blackwood and Gamal A. Norton