FDA 483 - Osteolife Biomedical I LLC - February 04, 2022

An FDA inspection of Osteolife Biomedical I LLC, a human tissue processor in Miami, FL, revealed significant and repeat deficiencies in their manufacturing processes for HCT/Ps, particularly particulate bone products. The firm failed to prevent communicable disease transmission, adequately validate processes, monitor environmental conditions, and properly investigate deviations, leading to the distribution of contaminated products. These issues indicate a severe lack of control over contamination and a deficient quality program.