# FDA 483 - Thompson Ocular Prosthetics, Inc - July 02, 2025

Source: https://www.globalkeysolutions.net/records/483/thompson-ocular-prosthetics-inc/12f05d00-d397-4647-9e6e-c28fedf29016

> FDA 483 for Thompson Ocular Prosthetics, Inc on July 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thompson Ocular Prosthetics, Inc
- Inspection Date: 2025-07-02
- Product Type: device
- Office Name: Dallas District Office
- Summary: Thompson Ocular Prosthetics, Inc. in San Antonio, TX, was inspected regarding its manufacturing of Class II medical devices. The inspection revealed significant and systemic failures in their quality management system, including repeat observations from a previous 2021 inspection. Key issues involved inadequate design controls, corrective and preventive actions, complaint handling, quality audits, management review procedures, and personnel training.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/thompson-ocular-prosthetics-inc/6c803653-c4bf-43b3-a35b-cee13f157ea1)

## Related Officers

- [Katlin N. Stubbs](https://www.globalkeysolutions.net/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.globalkeysolutions.net/companies/thompson-ocular-prosthetics-inc/124d2ae5-f910-4ec9-a870-c27dbec4798f

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