FDA 483 - GEO Medical Co., Ltd. - April 13, 2023

An FDA inspection of GEO Medical Co., Ltd. in Gwangju, Korea, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes after facility relocation, establish proper procedures for handling customer complaints, conduct thorough corrective and preventive actions, and maintain adequate design review records for their contact lenses. These observations indicate systemic issues in their quality management.