Gentell, Inc. - Aug. 25, 2015
Issue Date
Aug 25, 2015
Region
Central
Category
Device
$117.00
Contact Name
David A. Navazio
Contact Title
Executive Vice President
Address 1
2701 Bartram Rd.
City
Bristol
State
PA
Zip/Postal Code
19007-6810
Country
United States
Inspection Range
Jul 29, 2015 - Aug 25, 2015
Pages
6
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
Investigator(s): Edward D. McDonald