China NMPA Inspection - Anhui Kangtai Medical Equipment Co., Ltd. - July 07, 2017

Anhui Kangtai Medical Equipment Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration (SFDA) on June 6-7, 2017. The inspection, conducted under "Regulations on Unannounced Inspections of Drugs and Medical Devices," revealed 16 major deficiencies, indicating a failure to adhere to "Good Manufacturing Practice for Medical Devices" and its "Appendix for Sterile Medical Devices."Key violations included: a lack of medical examination reports for some operators and unhygienic practices among cleanroom staff. Facility issues comprised absent mosquito/fly prevention in outsourced areas and inadequate dust control in storage. Equipment deficiencies involved missing operating procedures, usage records for testing instruments, and calibration certificates for measuring devices. Furthermore, the company used obsolete documents for quality records and failed to comply with internal product labeling procedures.Anhui Kangtai is required to rectify these issues promptly, with potential follow-up inspections and product recalls under "Regulations on the Recall Management of Medical Devices." The SFDA also instructed the provincial bureau to enhance daily supervision, increase inspection frequency for problematic companies, and ensure strict implementation of manufacturing practices to safeguard medical device product safety and effectiveness.