FDA 483 - Terumo Cardiovascular Systems Corporation - March 29, 2010

This FDA Form 483 documents observations from an inspection, highlighting significant deficiencies in the facility's quality system and manufacturing processes. Management with executive responsibility failed to ensure the full implementation and maintenance of an adequate and effective quality system across all organizational levels.

Key violations include: - Inadequate investigation of nonconformities to determine root causes. - Failure to identify all necessary corrective and preventive actions (CAPA) to prevent recurrence of nonconforming products and quality issues. - Lack of verification or validation of CAPA to ensure effectiveness and prevent adverse effects on finished devices. - Absence of defined and implemented CAPA procedures utilizing appropriate statistical methodology for identifying existing and potential causes of nonconformities. - Insufficient documentation of CAPA activities, including verification/validation. - Unimplemented complaint handling procedures for receiving complaints. - Lack of established quality system procedures.

Regarding medical device reporting (MDR), the facility failed to: - Submit an MDR report within 30 days of becoming aware of information suggesting a marketed device caused or contributed to a death or serious injury. - Provide a complete description of the event, device involvement, and problem nature in Block B of FDA Form 3500A. - Submit supplemental reports within one month of receiving new information not included in initial reports.

Further issues include: - Failure to establish adequate quality requirements for suppliers. - Inadequate validation and approval of processes whose results cannot be fully verified