FDA 483 - DreamCon Co. Ltd. - May 08, 2023

DreamCon Co. Ltd., a manufacturer of Daily Wear Soft Contact Lenses, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of validation for the water purification process and inadequate procedures for acceptance activities. Additionally, the firm failed to adequately investigate product complaints or evaluate them for MDR reportability.