FDA WARNING_LETTER - NANHAI MEISHIDA BEAUTY EQUIPMENT CO., LTD - September 13, 2012

An FDA inspection of Nanhai Meishida Beauty Equipment Co., LTD in Foshan City, China, from September 10-13, 2012, revealed significant violations regarding their Model M-2040, 13 in 1 Beauty Instrument, classified as a medical device.

The device is misbranded under section 502(t)(2) of the Act for failing to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. The firm's October 5, 2012, response was inadequate, as it did not confirm employee training or implementation of new procedures, and the submitted procedures were not in English.

Furthermore, the device is adulterated under section 501(f)(1)(B) and misbranded under section 502(o) because the firm failed to obtain marketing approval or clearance (PMA or 510(k) notification) for the device, which includes "High-frequency function" and "galvanic function" with purported therapeutic effects.

Due to these violations, the Model M-2040, 13 in 1 Beauty Instruments are subject to refusal of admission into the U.S. under section 801(a) of the Act. The firm must provide a written response within fifteen business days detailing corrective