FDA WARNING_LETTER - Wonjin Mulsan Co., Ltd. - April 04, 2013

An FDA inspection of Wonjin Mulsan Co., Ltd. in South Korea from April 1-4, 2013, revealed that their POWER-Q1000 Compressible Limb Therapy System (Model WHF-314) devices are adulterated and misbranded. The devices are adulterated under Section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) requirements. Specific QS violations include failure to establish and maintain procedures for design validation (21 CFR 820.30(g)), verification/validation of corrective and preventive actions (CAPA) (21 CFR 820.100(a)(4)), documentation of CAPA activities (21 CFR 820.100(b)), maintaining complaint files and procedures (21 CFR 820.198(a)), investigating complaints (21 CFR 820.198(c)), acceptance of incoming product (21 CFR 820.80(b)), and maintaining device history records (DHRs) (21 CFR 820.184). The firm's responses to these observations were deemed inadequate, lacking systemic corrective actions and supporting evidence. Furthermore, the device is adulterated under Section 501(f)(1)(B) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under Section 502(o) for introducing the device with major changes to its intended use without submitting a new premarket notification (510(k)), specifically marketing for unapproved claims like prevention of limb paralysis and fat dissolution. These violations subject the devices to refusal of admission into the U.S. (detention without physical examination). The firm must provide a written response within fifteen business days detailing specific corrections, prevention plans, documentation, and a timetable for implementation to address these serious compliance issues. Failure to correct will impact federal contracts, PMA approvals, and Certificates to Foreign Governments.