FDA 483 - DCI Donor Services Tissue Bank - August 28, 2025

An FDA inspection of DCI Donor Services, Inc. in Nashville, TN, a human tissue processor, revealed three significant observations. The firm failed to properly determine donor eligibility for individuals with communicable disease risk factors, maintained facilities in a poor state of repair with chipping paint in cleanrooms, and did not clean manufacturing equipment according to established schedules, leading to visible tissue residue. These issues raise concerns about the quality and safety of processed musculoskeletal tissues.