FDA 483 - Terumo Cardiovascular Systems Corporation - August 11, 2008

This FDA 483 observation, without a specified company name or inspection dates, highlights significant deficiencies in the manufacturer's quality management system, indicating non-compliance with medical device regulatory requirements. Key issues include a pervasive lack of established or implemented procedures across critical operational areas. Specifically, the company failed to define and implement procedures for quality audits, control of design changes, design reviews at appropriate stages, and design validation. Design-related problems further extended to an incomplete risk analysis and unresolved discrepancies noted during design verification. Additionally, the facility lacked established procedures for implementing corrective and preventive actions (CAPA), and did not follow procedures for controlling non-conforming products. Complaint handling procedures were not defined or implemented, and a medical device report (FDA Form 3500A) was deficient in providing a comprehensive event description. The device history record did not align with the device master record, and software validation activities for computers used in the quality system were not documented. Furthermore, document control procedures were not implemented, and records of document changes were not maintained. Finally, supplier control procedures were incomplete, lacking clear agreements for notification of product or service changes. These observations necessitate immediate action to establish, document, and implement robust quality system procedures to ensure regulatory compliance and product quality.