CRS Medical Diagnostics, Inc. - October 1, 2009
Issue Date
Oct 01, 2009
Region
Central
Category
Device
$117.00
Address 1
14300 Redwood Dr.
Address 2
PO Box 510137
City
New Berlin
State
WI
Zip/Postal Code
53151
Country
US
Inspection Range
Sep 24, 2009 - Oct 01, 2009
Pages
3
First Observation
The design history file does not demonstrate that the design was developed following the approved design plan and the design control requirements of 21 CFR 820.
Investigator(s): Richard Jay Tucker