China NMPA Inspection - Foshan Boxin Biotechnology Co., Ltd. - July 14, 2017

Foshan Boxin Biotechnology Co., Ltd. underwent an unannounced inspection by the State Food and Drug Administration from June 20-21, 2017. The inspection, conducted under the "Regulations on Unannounced Inspections of Drugs and Medical Devices" and referencing "Good Manufacturing Practice for Medical Devices" (GMP) and its "Appendix: Sterile Medical Devices," identified several significant deficiencies.

Key violations included inadequate facility controls such as an undivided temporary storage area within the clean zone, a lack of daily temperature monitoring in the alcohol storage warehouse, and high humidity in a Class 100,000 cleanroom changing area. Process control issues were noted, including an inability to effectively observe particles during rinsing, neglected routine air conditioning maintenance, incomplete validation of the product coating process (missing parameter limits and proper special process identification), and overlapping cleanroom classifications during hemoperfusion device production. Furthermore, documentation problems involved arbitrary modifications to operation records for a multi-effect water distillation machine, and missing supplier evaluation data for a critical outsourced material.

In response, Foshan Boxin Biotechnology Co., Ltd. is required to rectify all identified issues promptly, potentially face follow-up inspections, and recall any products posing safety risks. The company must report its rectification efforts to the State Food and Drug Administration. Concurrently, the Guangdong Provincial Food and Drug Administration is mandated to strengthen daily supervision, increase inspection frequency for companies with noted deficiencies, analyze root causes, eliminate regulatory risks, and ensure strict adherence to GMP standards to uphold medical device product safety and effectiveness.