# FDA 483 - Somnomed Inc - May 23, 2025

Source: https://www.globalkeysolutions.net/records/483/somnomed-inc/b15df457-dc36-40d1-8b42-5d0497ea1de1

> FDA 483 for Somnomed Inc on May 23, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Somnomed Inc
- Inspection Date: 2025-05-23
- Product Type: device
- Office Name: Dallas District Office
- Summary: Somnomed Inc, a medical device manufacturer in Plano, TX, received a Form FDA 483 with five observations following an inspection. The firm was cited for deficiencies in its quality system, including inadequate procedures for complaint handling, acceptance activities, software validation, purchasing controls, and rework of nonconforming products. These issues indicate a lack of established and followed procedures across several critical areas of device manufacturing and quality assurance.

## Related Officers

- [Katherine M. Thames](https://www.globalkeysolutions.net/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [Yuliana Hernandez-Magana](https://www.globalkeysolutions.net/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)

Company: https://www.globalkeysolutions.net/companies/somnomed-inc/d48c0aa9-aba8-441e-b167-567ae67a58a7

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9