# FDA 483 - Utah Lions Eye Bank - April 23, 2024

Source: https://www.keypedia.com/records/483/utah-lions-eye-bank/d232179f-9388-4d21-b462-50a5ef3bccd8

> FDA 483 for Utah Lions Eye Bank on April 23, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Utah Lions Eye Bank
- Inspection Date: 2024-04-23
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Utah Lions Eye Bank revealed two significant observations. The firm failed to adequately investigate environmental monitoring deviations in its tissue processing room, which showed elevated colony forming units. Additionally, the inspection found deficiencies in record-keeping for environmental monitoring and cleaning procedures, indicating a lack of detailed documentation for critical operations.

## Related Officers

- [Dylan R. Jock](https://www.keypedia.com/people/dylan-r-jock/a083cb5e-95d7-491d-9c6d-8c36c5963ddf)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/utah-lions-eye-bank/5f8b6d0d-eceb-4c27-9aff-144dd35af8a2

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face