SCC Soft Computer - May 25, 2011
Issue Date
May 25, 2011
Region
Southeast
Category
Device
$117.00
Contact Name
Gilbert Hakim
Contact Title
CEO
Address 1
5400 Tech Data Dr.
City
Clearwater
State
FL
Zip/Postal Code
33760
Country
United States
Inspection Range
Apr 11, 2011 - May 25, 2011
Pages
30
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced with 21 CFR 820.
Investigator(s): Lisa K. Simone, Bill Tackett Jr., and Linda K. Weir