Eaton Manufacturing Corporation dba Eaton Medical - March 28, 2011
Issue Date
Mar 28, 2011
Region
Southeast
Category
Device
$117.00
Address 1
1401 Heistan Place
City
Memphis
State
TN
Zip/Postal Code
38104-4729
Country
US
Inspection Range
Mar 22, 2011 - Mar 28, 2011
Pages
5
First Observation
Written MDR procedures have not been developed.
Specifically, your firm failed to develop and implement MDR procedures as a manufacturer of a medical device.
Investigator(s): Erica M. KatherineSpecifically, your firm failed to develop and implement MDR procedures as a manufacturer of a medical device.