FDA WARNING_LETTER - GD Designs, Inc. - March 29, 2011

An FDA inspection of GD Designs, Inc. from February to March 2011 revealed that the firm's TherOzone T-8000 device is adulterated and misbranded. The device is adulterated under section 501(h) of the Act because manufacturing methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include failures to establish and maintain procedures for corrective and preventive actions (21 CFR 820.100(a)), design controls (21 CFR 820.30(a)), acceptance activities (21 CFR 820.80(a)), and quality audits (21 CFR 820.22). Additionally, the firm failed to ensure device history records included primary identification labels (21 CFR 820.184(e)) and to establish training procedures for personnel (21 CFR 820.25(b)). Beyond QS issues, the device is adulterated under 21 U.S.C. 351(f)(1)(B) due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It is also misbranded under 21 U.S.C. 352(o) for failing to submit a 510(k) premarket notification and for not fulfilling annual establishment registration and device listing requirements for fiscal year 2011. GD Designs committed to ceasing manufacturing and implementing a compliant Quality System by October 2011, but FDA deemed their responses inadequate. The firm must promptly correct all violations within fifteen business days to avoid regulatory actions such as seizure, injunction, civil money penalties, and impacts on federal contracts or device approvals.