483
Elutia IncElutia Inc – FDA 483, Dec 30, 2019
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.
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ID · 81a989d3-e06a-4a96-ab76-ab721168af91
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