# FDA 483 - CorneaGen, Inc. - July 29, 2022

Source: https://www.keypedia.com/records/483/corneagen-inc/b55b1715-158f-460d-a5f4-947987c7ca2e

> FDA 483 for CorneaGen, Inc. on July 29, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CorneaGen, Inc.
- Inspection Date: 2022-07-29
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Corneagen, Inc. in South San Francisco, CA, a human tissue establishment, was cited for two significant observations during an FDA inspection. The firm failed to validate processing steps for its ocular allograft products, raising concerns about contamination and the spread of communicable diseases. Additionally, the environmental monitoring program for ocular tissue processing was deemed inadequate, as monitoring was not performed at each processing event.

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)
- [investigator](https://www.keypedia.com/people/ka-l-wong/e624263d-e2c0-4b80-b5d9-ea84e29baa6b)

Company: https://www.keypedia.com/companies/corneagen-inc/57206953-05f1-4b04-8917-be34f14885c3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b