FDA 483 - Medimaging Integrated Solution, Inc. - July 05, 2018

Medimaging Integrated Solution, Inc. in Hsinchu, Taiwan, was inspected by the FDA from April to July 2018, resulting in a Form 483. The inspection revealed significant quality system deficiencies, including a lack of validation for manufacturing processes, inadequate nonconformance data analysis, unqualified suppliers, and insufficient production records for subassemblies. These issues indicate a need for improved quality control and documentation practices.