# FDA 483 - Elutia Inc - December 30, 2019

Source: https://www.globalkeysolutions.net/records/483/elutia-inc/81a989d3-e06a-4a96-ab76-ab721168af91

> FDA 483 for Elutia Inc on December 30, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elutia Inc
- Inspection Date: 2019-12-30
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: AZIYO BIOLOGICS in Roswell, GA, was inspected and received a Form FDA 483 with two observations. The inspection revealed inadequate documentation of design risk analysis, specifically concerning shelf-life changes for their CorMatrix CanGaroo ECM Envelope Products, and a failure to inform customers of these changes. Additionally, the firm failed to adequately document corrective and preventive action activities related to product failures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sayeeda-hdabe/eaadc7cf-5f22-47c2-ba02-437efe0a5267)

Company: https://www.globalkeysolutions.net/companies/elutia-inc/7b759f1e-6f5d-4404-bfa9-3411bdc84122

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