Futrex Incorporated - 11/5/2012
Issue Date
Nov 05, 2012
Region
Central
Category
Device
$117.00
Address 1
130 Western Maryland Pkwy
City
Hagerstown
State
MD
Zip/Postal Code
21740
Country
United States
Inspection Range
Oct 22, 2012 - Nov 05, 2012
Pages
6
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
Investigator(s): Cynthia A. Harris