FDA WARNING_LETTER - YANG MING INDUSTRY (ZHEJIANG) LIMITED - May 24, 2012

On August 15, 2012, the FDA issued a Warning Letter to Yang Ming Industry (Zhejiang) Limited (YMI) following an inspection from May 21-24, 2012, at their Pinghu, China facility. The inspection determined YMI manufactures the Shoprider Streamer Sport Power Wheelchair, classified as a medical device.

The inspection revealed the firm's devices are misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act, due to failure to furnish material or information required by section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting (MDR). A significant violation cited was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. YMI's representative stated that MDR is the responsibility of the parent company, Pihsiang Machinery Manufacturing Company (PMMC), and that YMI reports events to PMMC but lacks its own written MDR procedure. A draft outline provided during the inspection was deemed insufficient.

YMI was required to notify the FDA in writing within fifteen business days of receiving the letter, detailing specific corrective steps, including how similar violations will be prevented, and providing documentation of corrections and a timetable if actions extend beyond fifteen days. Failure to comply could result in U.S. federal agencies being advised,