# FDA 483 - VirtuSense Technologies, Inc. - September 18, 2025

Source: https://www.globalkeysolutions.net/records/483/virtusense-technologies-inc/9d72d603-be9b-4cbb-8e60-aaf516de5fdf

> FDA 483 for VirtuSense Technologies, Inc. on September 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VirtuSense Technologies, Inc.
- Inspection Date: 2025-09-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: VirtuSense Technologies, Inc. in Peoria, IL, was inspected by the FDA, revealing significant deficiencies in their quality system for manufacturing the Class II medical device, VST Balance. The inspection identified a pervasive lack of established and adequately implemented procedures across critical areas such as personnel training, complaint handling, CAPA, document control, quality policy, quality planning, quality audits, and management review. These findings indicate a fundamental breakdown in the firm's adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.globalkeysolutions.net/companies/virtusense-technologies-inc/b3db6d8c-5486-4878-b041-e385ebbca4dc

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