HANGZHOU FUSHAN MEDICAL APPLIANCES CO.,LTD – FDA EIR, Jun 2, 2016

An FDA inspection of Hangzhou Fushan Medical Appliances Co. Ltd. (HFMACL), a manufacturer and contract manufacturer of Class I and Class II medical devices, was conducted from May 30 to June 2, 2016. This comprehensive Quality System Regulation (QSR) Good Manufacturing Practice (GMP) Level II inspection focused on critical subsystems including management, design, corrective and preventive actions (CAPA), and production and process controls. The inspection was initiated following a previous audit in March 2014, which had identified a significant issue regarding an inadequate nonconformity control procedure, as well as minor observations concerning in-process material labeling, temperature monitoring, and Device History Record completeness. A primary objective of the 2016 inspection was to verify the resolution of these prior findings. The investigator confirmed that HFMACL had successfully implemented corrective measures for all previously identified issues. Specifically, the firm's nonconformance procedure was found to be adequately incorporated into its complaint process. Consequently, no new FDA Form 483 "Inspectional Observations" were issued during this inspection, indicating the company's compliance with the regulatory framework governing medical devices distributed in the USA.