# FDA 483 - Georgia Eye Bank, Inc. - May 24, 2019

Source: https://www.keypedia.com/records/483/georgia-eye-bank-inc/7cce4869-a420-4c24-a29b-86b4d75a83be

> FDA 483 for Georgia Eye Bank, Inc. on May 24, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Georgia Eye Bank, Inc.
- Inspection Date: 2019-05-24
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Georgia Eye Bank, Inc. in Atlanta, GA, identified a significant issue regarding process validation. The firm failed to establish and implement procedures to validate critical corneal processing methods, specifically for DMEK, DSEK, and LIKE procedures. This indicates a lack of control over processes that cannot be fully verified by inspection and tests.

## Related Officers

- [investigator](https://www.keypedia.com/people/leslie-w-gilbert/5c8b9e87-9563-4403-89ad-cfa3282a1ba5)

Company: https://www.keypedia.com/companies/georgia-eye-bank-inc/6fb2513a-c7e5-4957-9e38-fea6c411fb9a

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