# FDA 483 - Nantsound Inc - February 23, 2022

Source: https://www.keypedia.com/records/483/nantsound-inc/c3d94157-48ea-4194-8a3c-696ca7a57dcd

> FDA 483 for Nantsound Inc on February 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nantsound Inc
- Inspection Date: 2022-02-23
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Nantsound Inc. in Park Ridge, IL, revealed that the firm's procedures for the rework of nonconforming medical devices were not adequately established. Specifically, the firm failed to complete required deviation forms for reworked HD-100 Hearing Aids and did not document the serial numbers of these reworked devices on their SCARs. This indicates a significant lapse in quality system controls for handling nonconforming products.

## Related Officers

- [Natasha R. Johnson](https://www.keypedia.com/people/natasha-r-johnson/ae9e5ea3-74dd-427e-9f8b-32faa975679e)

Company: https://www.keypedia.com/companies/nantsound-inc/bc3f18ed-5051-434c-b7c5-deca7677d5bc

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669