Company
United StatesTheranos, Inc., Palo Alto, CA – FDA Inspections
Inspection records and compliance data for Theranos, Inc. in Palo Alto, California. 2 FDA inspections on record, last inspected August 18, 2016.
Company Profile
This profile covers Theranos, Inc. based in Palo Alto, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 16, 2015. Last inspected August 18, 2016.
Most cited issue areas
- Design input - documentation1 inspection
- Design validation - Risk analysis1 inspection
- Design validation - simulated testing1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 18, 2016 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 983845 |
| September 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 941546 |
FDA documents
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Company Information
Name
Theranos, Inc.
FEI Number
3010479366
Address
1701 Page Mill Rd, Palo Alto, California 94304, United States
Country
United States
ID: d7f8228b-8367-4145-8638-fc95aa8a0ee8