Rockwell Medical, Inc. - April 3, 2015
Issue Date
Apr 03, 2015
Region
Central
Category
Device
$117.00
Contact Name
Robert L. Chioini
Contact Title
CEO
Address 1
30142 S. Wixon Rd.
City
Wixon
State
MI
Zip/Postal Code
48393-3440
Country
United States
Inspection Range
Feb 17, 2015 - Apr 03, 2015
Pages
4
First Observation
The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
Investigator(s): Amy S. Graf and Deanna L. Lampley