# FDA 483 - Lions Eye Bank of Texas at Baylor College of Medicine - January 29, 2025

Source: https://www.keypedia.com/records/483/lions-eye-bank-of-texas-at-baylor-college-of-medicine/1fdcbb62-caae-4970-a468-c9433f09bb02

> FDA 483 for Lions Eye Bank of Texas at Baylor College of Medicine on January 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lions Eye Bank of Texas at Baylor College of Medicine
- Inspection Date: 2025-01-29
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Lions Eye Bank of Texas at Baylor College of Medicine, a human tissue-eye bank, revealed deficiencies in temperature monitoring practices. The firm failed to periodically review recorded storage temperatures and document the cause of temperature excursions for human tissue products. Additionally, the relevant SOP did not instruct personnel to document these causes.

## Related Officers

- [Elyshia Q. Danaher](https://www.keypedia.com/people/elyshia-q-danaher/73046c15-abb1-431e-8a76-59c7e8c1604a)
- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)

Company: https://www.keypedia.com/companies/lions-eye-bank-of-texas-at-baylor-college-of-medicine/16c934d8-7007-4e0a-a28b-eb6755dd4655

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