# FDA 483 - CorneaGen LLC - September 24, 2021

Source: https://www.globalkeysolutions.net/records/483/corneagen-llc/aae3dd26-9856-4ba9-97cd-4cf35aeecf0f

> FDA 483 for CorneaGen LLC on September 24, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CorneaGen LLC
- Inspection Date: 2021-09-24
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Corneagen Inc. in Seattle, WA, was inspected by the FDA from September 23-24, 2021, regarding its human tissue operations. The inspection revealed a significant deficiency in record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically the failure to include the address of the donor-eligibility determination establishment in records for distributed corneal tissues.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.globalkeysolutions.net/companies/corneagen-llc/d18bb473-fd82-468e-ad96-1d7f87189854

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822