FDA WARNING_LETTER - Virtual Sun, LLC - July 17, 2013

An FDA inspection of Virtual Sun, LLC, in Jemison, Alabama, on June 19 and July 17, 2013, determined that the firm's tanning beds, classified as medical devices, were adulterated. This was due to non-conformance with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 CFR Part 820). The inspection revealed numerous violations, including the failure to adequately establish and maintain procedures for corrective and preventive actions (CAPA) (21 CFR 820.100(a)), handling complaints (21 CFR 820.198(a)), and acceptance activities for incoming (21 CFR 820.80(b)) and in-process/final products (21 CFR 820.80(a)). The firm also failed to establish or maintain a device master file (21 CFR 820.181) and device history records (21 CFR 820.184). Further deficiencies included the lack of procedures for equipment calibration (21 CFR 820.72(a)), purchasing controls (21 CFR 820.50), and documented employee training (21 CFR 820.25(b)). Additionally, the devices were misbranded because the firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). While Virtual Sun, LLC provided a response outlining intentions to correct these issues, the FDA noted that required procedures were not provided. The FDA mandates prompt corrective action, including submitting revised procedures and a timetable within 15 working days, warning of potential regulatory actions such as seizure, injunction, civil money penalties, and impacts on federal contracts and device approvals if violations are not corrected.