Medtronic Xomed, Inc. - 7/25/2012
Issue Date
Jul 25, 2012
Region
Northeast
Category
Device
$117.00
Address 1
950 Flanders Rd
City
Mystic
State
CT
Zip/Postal Code
06355
Country
United States
Inspection Range
Jun 20, 2012 - Jul 03, 2012
Pages
4
First Observation
There is inadequate documentation of monitoring and control methods and a data for a validated process.
Investigator(s): Maryam Tabatabaie