Physician Software Systems, LLC - Nov. 24, 2014
Issue Date
Nov 24, 2014
Region
Central
Category
Device
$117.00
Contact Name
Lewis A. Mitchell
Contact Title
Chief Executive Officer
Address 1
3333 Warrenville Rd.
Address 2
Ste. 200
City
Lisle
State
IL
Zip/Postal Code
60532-1999
Country
United States
Inspection Range
Nov 18, 2014 - Nov 24, 2014
Pages
3
First Observation
The organization structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
Investigator(s): Shelton L. Stribling and Jesse A. Vazquez