China NMPA Inspection - Beijing Visidacom Technology Co., Ltd. - May 08, 2021

The National Medical Products Administration (NMPA) conducted an unannounced inspection of Beijing Visidacon Technology Co., Ltd., with findings announced on May 7, 2021. The inspection revealed serious deficiencies in the company's quality management system, non-compliant with the Good Manufacturing Practice for Medical Devices and its sterile medical device appendix. Key violations included: 1. Organization and Personnel: The management representative failed to oversee unauthorized activities involving semi-finished contact lenses, such as processing for external companies and training, demonstrating a lack of control over employee actions. 2. Production Management: Semi-finished contact lenses lacked proper batch number labeling and corresponding traceability records, making product traceability impossible, contrary to established procedures. 3. Quality Control: Critical factory inspection items, including refractive index and oxygen permeability, were intentionally omitted without providing supporting verification data, failing to adhere to mandatory standards and product technical requirements. As a result, the NMPA has ordered Beijing Visidacon Technology Co., Ltd. to immediately cease production and undertake comprehensive rectification. The company must also assess product safety risks and recall any potentially unsafe products. Resumption of production is contingent upon completing all required corrective actions and passing a re-inspection by the Beijing Municipal Drug Administration. Any regulatory violations will be dealt with seriously.