FDA 483 - Orchid Orthopedic Solutions Alabama LLC - June 15, 2023

An FDA inspection of Orchid Orthopedic Solutions Alabama LLC, a contract manufacturer of orthopedic solutions, revealed significant deficiencies in their quality system. Observations included inadequate procedures for handling nonconforming product rework and finished device acceptance, as well as an inadequately established and maintained organizational structure, particularly concerning quality management personnel roles and responsibilities.