# FDA 483 - CorneaGen Inc. - May 31, 2023

Source: https://www.keypedia.com/records/483/corneagen-inc/60652608-ec6e-495e-989d-a211cd094abf

> FDA 483 for CorneaGen Inc. on May 31, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CorneaGen Inc.
- Inspection Date: 2023-05-31
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Corneagen Inc., an eye bank in Winston Salem, NC, was cited for two observations during an FDA inspection. The firm failed to conduct environmental monitoring during the production of an in-house reagent used for processing corneas. Additionally, documentation for reagent verification was incomplete, lacking test results and vendor certificates of analysis for received reagents.

## Related Officers

- [investigator](https://www.keypedia.com/people/randy-l-clarida/aae3cc15-a908-4489-9299-7542370ad3cd)
- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/corneagen-inc/63b0f20d-2789-4c29-90c7-251cd951234a

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7