FDA 483 - Boston Scientific Corporation - April 07, 2005

During an inspection from March 9 to April 7, 2005, the FDA issued a Form 483 to Boston Scientific Corporation concerning its facility at 480 Pleasant Street. The inspection revealed multiple deficiencies in the company's quality management system, primarily affecting Vaxcel implantable vascular access systems. Key violations included incomplete corrective actions, specifically the omission of non-valved Vaxcel ports from a recall despite similar manufacturing processes and identified port separation issues in valved versions. The firm also failed to adequately validate its ultrasonic welding process for these critical medical device components, lacking comprehensive testing and revalidation after process changes. Further issues encompassed delays in notifying customers about product holds, inconsistent procedures for handling nonconforming products, inadequate complaint trending, and improper classification of shipping holds. Additionally, device history records were found to be incomplete, and incoming material inspection records showed procedural non-compliance. These observations highlight a need for Boston Scientific to enhance its adherence to medical device quality system regulations by implementing robust validation practices, improving nonconforming product controls, streamlining complaint handling, and ensuring comprehensive documentation to assure product safety and effectiveness.