FDA WARNING_LETTER - ProSun International, LLC - March 14, 2011

On August 15, 2011, the FDA issued a Warning Letter to ProSun International, LLC, following an inspection from March 9-14, 2011. The inspection revealed that the firm's Skin Rejuvenation/Collagen Beds and Sun Tanning Products are adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). The firm's April 18, 2011, response to the FDA 483 was not reviewed as it was not received within fifteen business days.

Key violations include: 1. Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)), specifically for Skin Rejuvenation Beds Models "ASR" and "SR." 2. Failure of management to conduct quality system reviews since 2003 (21 CFR 820.20(c)). 3. Failure to establish and conduct quality audits since 2003 (21 CFR 820.22). 4. Failure to maintain complaint files and adequately implement complaint handling procedures, not investigating service calls for malfunctioning timers as complaints (21 CFR 820.19