ALM Ortho Inc. – FDA 483, May 29, 2026

ALM Ortho Inc. in Scarborough, ME, was cited with five observations on a Form 483, indicating significant deficiencies in their quality management system for implantable medical devices. The firm failed to adequately validate sterilization processes, investigate critical device complaints including mislabeling and implanted devices, and complete design and software validations. These issues highlight a lack of control over essential manufacturing and quality assurance procedures.