DIAMOND ORTHOTIC LABORATORY – FDA 483, Nov 16, 2023

An FDA inspection of DIAMOND ORTHOTIC LABORATORY in La Mesa, CA, a manufacturer of orthotic devices, revealed significant deficiencies in their quality management system. Observations included a lack of established procedures for finished device acceptance, inadequate controls for manufacturing materials, and poorly maintained complaint files. Additionally, the firm failed to document personnel training, indicating systemic issues with their operational controls and record-keeping.