FDA EIR - Jiangsu Yuyue Medical Equipment & Supply Co. Ltd. - December 11, 2014

An FDA inspection of Jiangsu Yuyue Medical Equipment & Supply Co. Ltd., located in Danyang City, China, was conducted from December 8-11, 2014. The medical device manufacturer produces Class I and Class II devices, including oxygen cylinder regulators and wheelchairs, for which it holds 510(k) clearance for U.S. distribution. This comprehensive inspection followed compliance program 7382.845 for medical device manufacturers. Notably, previous observations from a 2012 inspection regarding design controls, complaint handling, Medical Device Reporting (MDR) procedures, and Device History Records were verified as corrected. While no FDA Form 483 was issued, two verbal observations were communicated: the sporadic omission of complainant addresses and phone numbers in complaint files, and the absence of specific 0-4L/min flow rate test specifications in one Device History Record for a special order oxygen tank regulator. In response, management committed to adding a column to the complaint-receiving files for comprehensive contact information within days, and revising the flow rate test form to include specifications for DHRs within one day. The inspection concluded with positive remarks on the firm's cooperation.