Fort Worth Eye Prosthetics, Inc. - 6/3/2011
Issue Date
Jun 03, 2011
Region
Southwest
Category
Device
$117.00
Address 1
801 Pennsylvania Ave.
City
Fort Worth
State
TX
Zip/Postal Code
76104
Country
United States
Inspection Range
May 31, 2011 - Jun 03, 2011
Pages
3
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): Saijal Naik