# FDA EIR - Theranos, Inc. - September 16, 2015

Source: https://www.keypedia.com/records/eir/theranos-inc/008171a5-1de8-46d5-aa30-8abe6ed4ebd3

> FDA EIR for Theranos, Inc. on September 16, 2015. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Theranos, Inc.
- Inspection Date: 2015-09-16
- Product Type: devices
- Office Name: San Francisco District Office
- Summary: An FDA "For Cause" Level II QSIT inspection of Theranos, Inc. was conducted from August 25 to September 16, 2015, at its Newark, CA facility. The inspection focused on the company's Class II In Vitro Diagnostic medical devices, specifically their Capillary Tube Nanotainers (CTNs). Throughout the inspection, Theranos repeatedly challenged the FDA's jurisdiction, asserting their product was under CLIA Lab control, not a Class II medical device requiring 510(k) clearance, despite prior FDA communication. The inspection identified several significant violations, leading to the issuance of a Form FDA-483. Key observations included the unapproved shipping of uncleared Class II medical devices in interstate commerce, inadequate complaint handling procedures where device failures were not properly investigated, and deficiencies in documenting Corrective and Preventive Actions (CAPA). Further issues involved the use of unvalidated software, failure to document supplier evaluations or establish acceptable supplier records, inadequate Device History Record procedures (e.g., not retaining product labels), and the absence of internal quality audits. Theranos' President and COO received the 483, indicating most observations would be corrected within seven days, with a formal written response promised within 15 working days, notwithstanding ongoing objections to the FDA's authority.

## Related Documents

- [483 - 2015-09-16](https://www.keypedia.com/records/483/theranos-inc/c2488720-56cf-443d-96e1-995bbde1e34a)
- [483 - 2015-09-16](https://www.keypedia.com/records/483/theranos-inc/4bf2d7b3-9a67-4158-8785-fc88463ae330)
- [483 - 2016-08-18](https://www.keypedia.com/records/483/theranos-inc/747fff74-ecf8-4b6d-800c-2b663f398278)

## Related Officers

- [Stayce E. Beck](https://www.keypedia.com/people/stayce-e-beck/8762c94c-a3d3-493f-aedc-4b1a1b2e8b6b)
- [Supervisory Investigator](https://www.keypedia.com/people/mary-r-hole/b81e185e-cf89-4d00-960b-c0f2b006dcd0)
- [Senior Advisor](https://www.keypedia.com/people/yung-w-chan/d36960ee-f319-4dfb-a2f4-701e30ea466a)

Company: https://www.keypedia.com/companies/theranos-inc/4e4c2926-eed7-47c0-9d4b-4d6e33261e8c

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df