FDA WARNING_LETTER - Zhongshan Mei Tung Electronics Ltd. - June 25, 2014

An FDA inspection of Zhongshan Mei Tung Electronics Ltd. in Zhongshan, China, from June 23-25, 2014, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803). The firm manufactures digital thermometers, nasal aspirators, liquid medication dispensers, and manual toothbrushes, which are deemed adulterated under section 501(h) and misbranded under section 502(t)(2) of the Act. The firm's responses to the FDA 483 were found inadequate. Key violations include failures in establishing and maintaining procedures for complaint handling (21 CFR 820.198), corrective and preventive action (21 CFR 820.100(a)), acceptance of incoming product (21 CFR 820.80(b)), acceptance of in-process product (21 CFR 820.80(c)), and written MDR procedures (21 CFR 803.17). The FDA requires a written response within fifteen business days detailing specific corrective actions, prevention plans, and a timetable for implementation. Failure to correct these systemic issues will result in refusal of admission for devices into the U.S. (detention without physical examination), potential impact on federal contracts, and non-approval of premarket applications for Class III devices.