Electronic Development Labs, Inc. - Nov. 5, 2013
Issue Date
Nov 05, 2013
Region
Southeast
Category
Device
$117.00
Contact Name
Donald M. Polsky
Contact Title
Engineering/CEO
Address 1
244 Oakland Dr.
City
Danville
State
VA
Zip/Postal Code
24540-7342
Country
United States
Inspection Range
Oct 29, 2013 - Nov 05, 2013
Pages
1
First Observation
The design history file was not established and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Sean R. Moynihan