# FDA 483 - Texas Eye Prosthetics, LLC - August 12, 2019

Source: https://www.globalkeysolutions.net/records/483/texas-eye-prosthetics-llc/5caafb6e-c358-4092-b333-bf4f50021ee9

> FDA 483 for Texas Eye Prosthetics, LLC on August 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texas Eye Prosthetics, LLC
- Inspection Date: 2019-08-12
- Product Type: device
- Office Name: Dallas District Office
- Summary: Texas Eye Prosthetics, LLC in Houston, TX, a medical device establishment, was inspected by the FDA from August 6-12, 2019. The inspection revealed five observations related to inadequate quality system procedures, including issues with CAPA documentation, labeling controls, device history records, equipment calibration, and control of nonconforming product. These observations indicate significant deficiencies in the firm's quality management system.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/texas-eye-prosthetics-llc/65f9264f-9890-421c-9be5-7434220d245f)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/texas-eye-prosthetics-llc/5fa068c0-e42f-43df-b907-c0e68161bfdf

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