China NMPA Inspection - Beijing Otikajey Contact Lens Manufacturing Co., Ltd. - June 28, 2018

An unannounced inspection of Beijing Otika Jieyi Contact Lens Manufacturing Co., Ltd., conducted from June 4-5, 2018, by the FDA NMPA, revealed several significant deficiencies. The inspection, based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*, identified seven main violations. Key issues included a quality manager whose educational background did not meet documented requirements, inadequate temperature control in the raw material warehouse for sensitive chemicals, and inconsistencies in production batch record documentation. Furthermore, critical equipment like a focimeter lacked proper verification and calibration records. Environmental control was compromised, with corrosion observed on equipment within the cleanroom, posing contamination risks. The company also failed to provide validation records for initial microbial and particulate contamination levels for packaging materials. Finally, discrepancies were found in batch production records regarding sterilization parameters and equipment usage. As a result, the company has been ordered to rectify these problems, assess product safety risks, and initiate product recalls if safety hazards are identified. Follow-up inspections are anticipated, and the Beijing Municipal Food and Drug Administration must report compliance to the National Medical Products Administration.