# FDA 483 - Immersivetouch Inc - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/immersivetouch-inc/4fe0b6f6-405c-4171-a603-362e69321867

> FDA 483 for Immersivetouch Inc on September 14, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immersivetouch Inc
- Inspection Date: 2023-09-14
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Immersivetouch Inc. in Chicago, IL, revealed significant deficiencies in their quality management system. The firm failed to adequately establish design change procedures for their ImmersiveView™Software, a repeat observation, and did not perform required internal quality audits for multiple years. These findings indicate a lack of adherence to established quality system requirements for medical device manufacturing.

## Related Documents

- [483 - 2020-01-29](https://www.globalkeysolutions.net/records/483/immersivetouch-inc/7f672c30-79e9-4876-b638-9e58a36da72b)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/immersivetouch-inc/daae7a4d-62b5-4e26-84e0-b14b8641588a

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