Tenacore Holdings, Inc. - Aug. 8, 2014
Issue Date
Aug 08, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Peter J. Bonin
Contact Title
CEO
Address 1
1525 E. Edinger Ave.
City
Santa Ana
State
CA
Zip/Postal Code
92705-4907
Country
United States
Inspection Range
Jul 30, 2014 - Aug 08, 2014
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): Angela Shepas