# FDA 483 - Theranos, Inc. - September 16, 2015

Source: https://www.keypedia.com/records/483/theranos-inc/c2488720-56cf-443d-96e1-995bbde1e34a

> FDA 483 for Theranos, Inc. on September 16, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Theranos, Inc.
- Inspection Date: 2015-09-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Theranos, Inc., a medical device manufacturer in Newark, CA, was inspected by the FDA from August 25 to September 16, 2015. The inspection revealed significant deficiencies across its quality management system, including unlisted medical devices, inadequate complaint handling, undocumented corrective actions, unvalidated software, and poor supplier controls. These findings indicate a systemic failure to comply with medical device regulations.

## Related Documents

- [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/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b