Mega Sun Inc – FDA Warning Letter, Mar 6, 2013

On February 28 through March 6, 2013, an FDA inspection of Mega Sun Inc. at 4515 Miami Street, St. Louis, Missouri, revealed significant deviations from current good manufacturing practice regulations for medical devices (21 CFR Part 820). The firm's tanning beds (Slim Line, Mega Max, Mega V, Crossfire/Extreme models) are considered medical devices, and these deviations render them adulterated under Section 501(h) of the Food, Drug, and Cosmetic Act.

Violations include: 1. Failure to ensure the quality policy is understood, implemented, and maintained (21 CFR 820.20(a)), evidenced by lack of training and consistent failure to record information on quality control checklists in device history records since May 5, 2012. 2. Failure to adequately establish procedures for finished device acceptance (21 CFR 820.80(d)), with examples like the Mega Max model's specification charts listing "amp draw" outside acceptable ranges. 3. Failure to adequately maintain device history records (21 CFR 820.184), with consistent omissions of required information, signatures, and dates in quality control checklists. 4. Failure to conduct quality audits (21 CFR 820.22), despite a procedure requiring audits at least (b)(4)