# FDA 483 - Thompson Ocular Prosthetics, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/thompson-ocular-prosthetics-inc/6c803653-c4bf-43b3-a35b-cee13f157ea1

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

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## Details

- Record Type: 483
- Company Name: Thompson Ocular Prosthetics, Inc
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Thompson Ocular Prosthetics, Inc. in San Antonio, TX, a medical device manufacturer, revealed ten significant quality system deficiencies, many of which were repeat observations from a previous inspection. Key issues included failures in quality audits, corrective and preventive action procedures, complaint handling, management review, incoming product acceptance, design control, and Unique Device Identification (UDI) compliance. The firm manufactures Class I Artificial Eyes and Class II Scleral Shells and Ophthalmic Conformers.

## Related Documents

- [483 - 2025-07-02](https://www.globalkeysolutions.net/records/483/thompson-ocular-prosthetics-inc/12f05d00-d397-4647-9e6e-c28fedf29016)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gilbert-valdez/9226d7ad-71e9-41b0-977e-8de133999b6a)

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