Auxogyn, Inc. - May 29, 2013
Issue Date
May 29, 2013
Region
Pacific
Category
Device
$117.00
Contact Name
Lissa A. Goldenstein
Contact Title
President & CEO
Address 1
1490 Obrien Dr.
Address 2
Ste A
City
Menlo Park
State
CA
Zip/Postal Code
94025-1432
Country
United States
Inspection Range
May 20, 2013 - May 29, 2013
Pages
2
First Observation
Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
Investigator(s): Alla Dubrovsky