# FDA 483 - BEYOND AIR - September 23, 2021

Source: https://www.keypedia.com/records/483/beyond-air/4942c91e-a1e8-48bb-9734-3e8e81bcde09

> FDA 483 for BEYOND AIR on September 23, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BEYOND AIR
- Inspection Date: 2021-09-23
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of BEYOND AIR in Madison, WI, from September 20-23, 2021, revealed that procedures for design validation were not adequately established or implemented. Specifically, the firm's design validation test report for LungFit PH electrode reliability lacked sufficient data to demonstrate that testing units met required continuous NO delivery rates. This indicates a significant issue with the firm's design control processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-t-domer/8e2d2ff5-b0da-4b0d-bd65-492a49ae1035)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/beyond-air/ec6a3b34-d5a1-4d35-a90b-fde2b0f66cfc

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d