Elutia IncDecember 30, 2019

FDA 483 - Elutia Inc - December 30, 2019

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Record Details

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.

Company: Elutia Inc
Inspection Date: December 30, 2019
Product Type: Biologics
Office: Atlanta District Office
Person: Sayeeda Hdabe (investigator)

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ID · 81a989d3-e06a-4a96-ab76-ab721168af91