# FDA 483 - Soma Technology Inc - February 18, 2026

Source: https://www.keypedia.com/records/483/soma-technology-inc/afa10650-c8fb-49f4-a0dd-a3a23047d6ef

> FDA 483 for Soma Technology Inc on February 18, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Soma Technology Inc
- Inspection Date: 2026-02-18
- Product Type: device
- Office Name: New England District Office
- Summary: Soma Technology Inc., an importer of medical devices in Bloomfield, CT, was inspected by the FDA. The inspection revealed a significant failure to establish and implement written Medical Device Reporting (MDR) procedures, indicating a lack of compliance with federal regulations for device reporting. This could lead to unreported adverse events related to medical devices.

## Related Officers

- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.keypedia.com/companies/soma-technology-inc/e8d7679b-aa46-46ed-b272-6e5daa48d07a

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144