# FDA 483 - CorneaGen - Boston - June 09, 2023

Source: https://www.globalkeysolutions.net/records/483/corneagen-boston/83adf46e-9bd2-45b5-bdec-816b54f14c32

> FDA 483 for CorneaGen - Boston on June 09, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CorneaGen - Boston
- Inspection Date: 2023-06-09
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of CorneaGen - Boston, a human tissue establishment, revealed significant deficiencies in environmental monitoring and reagent control. The firm failed to monitor environmental conditions during the production of in-house reagents used for cornea processing. Additionally, documentation for reagent verification lacked test results and certificates of analysis, and receipt records were missing critical information like manufacturer and expiration dates.

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## Related Officers

- [Lorayne A McGuinness](https://www.globalkeysolutions.net/people/lorayne-a-mcguinness/537b1a24-c006-49d9-9d24-5701c7124f9c)
- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7