FDA 483 - MinXray Inc - August 02, 2022

MinXray Inc, an X-Ray Assembler and Importer in Northbrook, IL, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, including proper documentation for Medical Device Report evaluations and consistent complaint investigations. Additionally, procedures for corrective and preventive actions were not adequately implemented, lacking identification of all quality data sources and documentation of effectiveness checks.