FDA 483 - DreamCon Co. Ltd. - May 11, 2023

An FDA inspection at DreamCon Co., Ltd., conducted from May 9-11, 2023, resulted in the issuance of a Form FDA 483, citing three significant observations regarding the company's manufacturing and quality control of soft contact lenses. The primary issues included a failure to adequately validate production processes, specifically noting that acceptance criteria for critical parameters were not properly established or re-evaluated for various lens types, such as Daily Smart and Day Dream Color Contact Lenses. Additionally, the firm lacked sufficient procedures for the acceptance or rejection of finished medical devices, as evidenced by ill-defined acceptance criteria for DESCH Contact Lenses. Finally, DreamCon did not maintain adequate controls for nonconforming products, failing to consistently identify, segregate, and document investigations for all affected lens types. These observations highlight areas where the company needs to improve its adherence to medical device Good Manufacturing Practices (GMP) as outlined under the Federal Food, Drug, and Cosmetic Act. DreamCon Co., Ltd. is expected to implement comprehensive corrective actions to address these deficiencies, ensuring product quality, safety, and regulatory compliance.