FDA 483 - OsteoLife Biomedical, LLC - January 27, 2022

An FDA inspection of OsteoLife Biomedical, LLC in Jupiter, FL, an HCT/P storage and distribution facility, revealed significant deficiencies. The firm failed to establish and implement a tracking system for HCT/Ps from donor to consignee. Additionally, the company lacked appropriate procedures for core CGTP requirements, including environmental control, product recall, and product receipt, storage, and distribution.