FDA 483 - Berkeley Biologics LLC - September 25, 2023

Elutia Inc. in Richmond, CA, was cited with five observations on a Form 483 inspection report. The inspection revealed significant issues with the validation of viable bone matrix manufacturing processes for several product lines, indicating a failure to prevent contamination. Additionally, the firm repeatedly determined donors with sepsis or septic shock eligible, lacked adequate procedures for donor eligibility, failed to provide complete medical records to the medical director, and used unqualified personnel for sepsis evaluations.