FDA 483 - Lake Superior Centre For Regenerative Medicine - September 12, 2025

Lake Superior Centre For Regenerative Medicine, a tissue processor in Thunder Bay, was cited for five observations related to inadequate process validation, insufficient procedures to prevent communicable disease transmission, and poor facility maintenance. The inspection revealed significant deficiencies in aseptic processing controls and environmental cleanliness, increasing the risk of contamination for human bone grafts. These issues indicate a failure to ensure the safety and quality of distributed HCT/Ps.