FDA WARNING_LETTER - Costumes For Your Eyes - October 15, 2010

An FDA inspection of Costumes For Your Eyes in Inver Grove Heights, Minnesota, from October 4-15, 2010, revealed significant violations concerning the firm's decorative, corrective, and non-corrective contact lenses, which are classified as medical devices. The inspection found the devices to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. The devices were also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Furthermore, the firm failed to fulfill annual establishment registration (section 510(b)(2)) and device listing (section 510(j)(2)) requirements for fiscal year 2010. The devices were also deemed adulterated under section 501(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Specifically, the firm failed to establish and maintain an appropriate quality system as required by 21 CFR 820.5, lacking documented procedures for management controls, design controls, corrective and preventive actions, production and process controls, complaint handling, supplier controls, and control of non-conforming products. The FDA requires prompt corrective action within 15 working days, including a plan to prevent recurrence and a timetable for implementation. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, PMA approvals, and Certificates to Foreign Governments.