# FDA 483 - Rocky Mountain Lions Eye Bank - September 27, 2024

Source: https://www.keypedia.com/records/483/rocky-mountain-lions-eye-bank/80b550d9-e23a-485f-92ee-5355e17e2c51

> FDA 483 for Rocky Mountain Lions Eye Bank on September 27, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rocky Mountain Lions Eye Bank
- Inspection Date: 2024-09-27
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Rocky Mountain Lions Eye Bank in Aurora, CO, revealed critical deficiencies in donor eligibility determination and screening processes. The firm failed to properly identify and exclude donors with risk factors for communicable diseases, including sepsis, Zika Virus, and West Nile Virus. Additionally, the firm's written procedures were inadequate to ensure compliance with donor eligibility requirements, and its quality program did not ensure proper training for personnel involved in donor screening.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/rocky-mountain-lions-eye-bank/a70245a1-55c2-4c8f-b151-b578bb1c331d

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