# FDA 483 - Immersivetouch Inc - January 29, 2020

Source: https://www.globalkeysolutions.net/records/483/immersivetouch-inc/7f672c30-79e9-4876-b638-9e58a36da72b

> FDA 483 for Immersivetouch Inc on January 29, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immersivetouch Inc
- Inspection Date: 2020-01-29
- Product Type: device
- Office Name: Chicago District Office
- Summary: ImmersiveTouch Inc. in Chicago, IL, a device manufacturing firm, was inspected by the FDA from January 23-29, 2020. The inspection revealed significant deficiencies in the design control processes for their ImmersiveView® software, a Class II device. Specifically, the firm failed to perform design validation and verification, adequately review and approve design inputs and outputs, and establish proper procedures for design changes.

## Related Documents

- [483 - 2023-09-14](https://www.globalkeysolutions.net/records/483/immersivetouch-inc/4fe0b6f6-405c-4171-a603-362e69321867)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

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