FDA Inspection
Theranos, Inc.Theranos, Inc. – FDA Inspection, Sep 16, 2015
Record Details
This FDA Inspection record concerns Theranos, Inc., with an inspection on September 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Theranos, Inc.
- Inspection Date
- September 16, 2015
- Product Type
- Devices
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ID · e1926af8-1b58-46bc-8afc-ba8e7e4555d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 941546
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Theranos, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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