Integrated Medical Systems International, Inc. - Jan. 14, 2015
Issue Date
Jan 14, 2015
Region
Central
Category
Device
$117.00
Contact Name
Laura M. Mather
Contact Title
VP of Administration and Strategy
Address 1
4575 Hudson Dr.
City
Stow
State
OH
Zip/Postal Code
44224-1725
Country
United States
Inspection Range
Jan 07, 2015 - Jan 14, 2015
Pages
3
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Benjamin J. Dastoli