China NMPA Inspection - Tianjin Taishikang Medical Technology Co., Ltd. - December 13, 2018

An unannounced inspection by the National Medical Products Administration (NMPA) of Tianjin Taishikang Medical Technology Co., Ltd., conducted from November 9-10, 2018, revealed significant non-compliance with the Good Manufacturing Practice for Medical Devices, specifically concerning their Hemodialysis Concentrate product.

The inspection identified numerous deficiencies across several areas. Facility and equipment issues included stains on cleanroom ceilings, rusty handling equipment, improper storage of raw materials, packaging, and retention samples, and inadequate monitoring equipment calibration and record-keeping. Significant documentation and procedural violations were noted, such as the company's failure to identify current regulatory documents, inconsistent signatures in monitoring records, incomplete process verification reports, undefined process parameters, and missing batch numbers in production records. Quality control shortcomings included insufficient detail in inspection records for finished products and raw materials, and a lack of defined departmental responsibility for non-conforming product records.

As a result, the Tianjin Municipal Drug Administration ordered Tianjin Taishikang Medical Technology Co., Ltd. to rectify all identified issues within a specified period. The company is also required to assess product safety risks and, if necessary, initiate recalls for any products posing safety hazards. Follow-up inspections will be conducted, and the rectification progress must be reported to the National Medical Products Administration.