CPR Medical Devices, Inc. – FDA Warning Letter, Jul 14, 2011

The FDA issued a Warning Letter to CPR Medical Devices, Inc. following an inspection from July 11-14, 2011, in Ontario, Canada. The firm manufactures hand-held resuscitator devices, which are classified as medical devices. The inspection revealed that the devices are adulterated because the manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Key violations include the failure to adequately establish and maintain procedures for corrective and preventive actions (21 CFR 820.100(a)), complaint handling (21 CFR 820.198(a)), and complaint investigation (21 CFR 820.198(b)). The firm also failed to ensure design requirements address patient needs (21 CFR 820.30(c)), maintain finished device acceptance procedures (21 CFR 820.80(d)), control changes to specifications (21 CFR 820.70(b)), and establish adequate purchasing controls (21 CFR 820.50(b)). Critically, the firm failed to maintain a Device Master Record (DMR) for its Oxylator products (21 CFR 820.181), leading to unverified specifications and unapproved changes. These deficiencies indicate systemic problems in the firm's quality management systems. CPR Medical Devices must notify the FDA within fifteen business days with specific corrective actions, a plan to prevent recurrence, and a timetable for implementation. Failure to correct these violations could impact federal contracts, premarket approvals for Class III devices, and the issuance of Certificates to Foreign Governments. The letter emphasizes the firm's responsibility for overall compliance.