FDA 483 - Osteolife Biomedical I LLC - February 14, 2023

Osteolife Biomedical I LLC, a human tissue processor in Miami, FL, was inspected by the FDA from February 6-14, 2023. The inspection revealed a significant issue with process validation, specifically concerning the bioburden determination for recently revalidated aseptic bone products. This indicates a failure to ensure that critical manufacturing processes are adequately controlled and verified.