FDA WARNING_LETTER - O'Ryan Industries, Inc. - May 13, 2008

An FDA inspection of a firm in Vancouver, Washington, from April 28-30, 2008, and May 13, 2008, revealed significant violations regarding the manufacture of the ENDO 150 endoscopic light source and import of the Omega ST Sterilizer (autoclave). These devices are considered adulterated because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. They are also misbranded due to failure to submit a 510(k) premarket notification.

Furthermore, the devices are adulterated under section 501(h) of the Act, as manufacturing, packing, storage, or installation methods do not conform to current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulations (21 CFR Part 820). The inspection identified 12 specific Quality System Regulation violations, including the absence of management commitment to quality, lack of quality audit procedures, no control for nonconforming products, inadequate equipment calibration, insufficient acceptance activities, no corrective and preventive action procedures, and failure to establish complaint handling, device master records (DMRs), device history records (DHRs), quality system records (QSRs), finished device distribution controls, and design change procedures. Additionally, the firm failed to develop Medical Device Reporting (MDR) procedures (21 CFR 803.17).