FDA WARNING_LETTER - Care Rehab and Orthopaedic Products, Inc. - January 10, 2008

An FDA inspection of Care Rehab and Orthopaedic Products, Inc. from December 2007 to January 2008 revealed that the firm's manufactured and distributed therapeutic and diagnostic devices are adulterated and misbranded. The devices are adulterated under 21 U.S.C. 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) requirements. Key QS violations include failure of management to appoint a quality system authority, inadequate complaint investigations (e.g., for burns/shocks), lack of process validation for testing software, absence of quality audits since April 2005, release of devices before completion of Device Master Record activities, insufficient design control documentation for Class II electrodes, and uncalibrated equipment. The devices are also misbranded under 21 U.S.C. 352(t)(2) for failing to comply with Medical Device Reporting (MDR) regulations (21 CFR Part 803). MDR violations include failure to submit reports within 30 days for serious injuries, not forwarding adverse event information for non-manufactured devices, not documenting decisions not to file MDRs, and lacking comprehensive written MDR procedures. The firm's responses to most observations were deemed inadequate. FDA also requested information regarding apparently defective lead wires. The firm must promptly correct all violations, provide documentation, and a timetable to avoid regulatory actions such as seizure, injunction, civil money penalties, and impacts on federal contracts and premarket approvals.