# FDA 483 - CorneaGen - Boston - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/corneagen-boston/8df31cfa-8379-47c9-8841-a09d6d074a37

> FDA 483 for CorneaGen - Boston on December 20, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CorneaGen - Boston
- Inspection Date: 2024-12-20
- Product Type: biologics
- Office Name: New England District Office
- Summary: CorneaGen - Boston, a human tissue establishment, was cited for significant deficiencies related to donor eligibility and product distribution during an FDA inspection. The firm failed to properly determine ineligible donors with clinical evidence of sepsis and distributed corneas before completing donor eligibility determinations. These issues indicate a serious lapse in ensuring the safety and suitability of human tissue products.

## Related Documents

- [483 - 2023-06-09](https://www.globalkeysolutions.net/records/483/corneagen-boston/83adf46e-9bd2-45b5-bdec-816b54f14c32)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)

Company: https://www.globalkeysolutions.net/companies/corneagen-boston/78964c02-d403-4377-8609-2434e1adaef8

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144