Theranos, Inc. - Sept. 16, 2015
Issue Date
Sep 16, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Elizabeth A. Holmes
Contact Title
Chief Executive Officer and Founder
Address 1
1701 Page Mill Rd.
City
Palo Alto
State
CA
Zip/Postal Code
94303-1111
Country
United States
Inspection Range
Aug 25, 2015 - Sep 16, 2015
Pages
4
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Ian A. Pilcher and Seema S. Singh