# FDA 483 - Ataia, Inc - March 07, 2022

Source: https://www.keypedia.com/records/483/ataia-inc/ad7cd870-c5b4-4e7b-9a90-2e902bb458d8

> FDA 483 for Ataia, Inc on March 07, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ataia, Inc
- Inspection Date: 2022-03-07
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Ataia, Inc., a medical device manufacturer in Silver Spring, MD, was inspected and cited for significant deficiencies in its quality system. The inspection revealed issues with the design history file for its SPEAX Communication System, including inadequate design input/output, unvalidated software, and uncontrolled design changes. Additionally, the firm failed to validate software used in production and its quality system, including electronic record storage and final inspection processes.

## Related Officers

- [Lindsey L Kirsh](https://www.keypedia.com/people/lindsey-l-kirsh/78c606cb-8c62-4b99-9e71-56ab53ed2a3c)
- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/ataia-inc/e58ba0d5-e439-4bf1-bef8-b3c2fc7d1e17

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64