# FDA 483 - Genesis Software Innovations LLC. - March 13, 2025

Source: https://www.keypedia.com/records/483/genesis-software-innovations-llc/6efcddcd-15d9-41e2-821a-eb47e0cc0305

> FDA 483 for Genesis Software Innovations LLC. on March 13, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Genesis Software Innovations LLC.
- Inspection Date: 2025-03-13
- Product Type: device
- Office Name: Detroit District Office
- Summary: Genesis Software Innovations LLC, a medical device firm in Grand Rapids, MI, was cited for failing to validate software used in its quality system. The inspection revealed a lack of established processes for addressing active cybersecurity vulnerability threats to their Preview Shoulder software device, resulting in multiple unaddressed high-severity findings. This indicates a significant deficiency in their quality management system regarding software integrity.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/genesis-software-innovations-llc/668c5fa2-4d83-47d7-89d3-fd8948b2015e

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03