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

Between September 8 and September 12, 2025, the FDA inspected Lake Superior Centre For Regenerative Medicine, a tissue processing facility in Thunder Bay, Ontario. The inspection revealed several significant violations regarding the processing of human bone tissue, specifically frozen cortical shafts. Key issues included the failure to validate manufacturing processes used since 2021 and inadequate procedures to prevent the spread of communicable diseases. Investigators observed that cleaning protocols did not follow manufacturer instructions for disinfectant contact times, leading to the detection of fungi and yeast in cleanrooms. Furthermore, staff demonstrated poor aseptic techniques, such as crawling on cleanroom floors during cleaning, failing to change contaminated gloves, and improperly handling sterile supplies. The facility also failed to maintain a sanitary environment, as evidenced by a dead insect found near sterile supplies and degraded flooring in processing areas. These observations were issued under the Federal Food, Drug, and Cosmetic Act to highlight conditions that could lead to product contamination. The firm is required to address these findings by discussing corrective actions with the FDA or submitting a formal written response detailing their plan to achieve compliance with safety standards.