FDA 483 - Vision Science Co., Ltd. - November 16, 2023

An FDA inspection of Vision Science Co., Ltd. in Daegu, Korea, a manufacturer of iSENS class II soft color contact lenses, revealed significant deficiencies in their quality system. Observations included inadequate corrective and preventive action procedures, failure of manufacturing equipment to meet specified requirements due to lack of environmental monitoring documentation, and the absence of established procedures for device history records. These findings indicate a need for comprehensive improvements in the firm's quality management.