FDA 483 - Legend Aerospace, Inc. - May 27, 2022

Legend Aerospace, Inc. in Medley, FL, a manufacturer and repackager/relabeler of medical devices, was inspected and cited for six observations related to its quality system. The firm failed to establish adequate procedures for complaint handling, Medical Device Reporting (MDR), corrective and preventive actions, servicing activities, control of nonconforming product, and supplier management. Several observations were repeats from a previous inspection in 2017, indicating persistent quality system deficiencies.