FDA 483 - Boston Scientific Corporation - September 01, 2005

The FDA Form 483 inspection revealed multiple deficiencies in the facility's quality system and manufacturing processes.

**Quality System and Audit Deficiencies:** * **Incomplete Audit Procedures:** The CRM Audit Procedure 005014 lacked specific details in the 2005 CAPA Audit Plan, failing to ensure complete coverage of QSR requirements, particularly regarding non-conforming data sources. * **Inadequate Corrective and Preventive Actions (CAPA):** Root cause was not determined for TR 05013 Rev. B 06/22/05 INSIGNIA, concerning "no output" and "fails to deliver therapy" issues. No CAPAs were implemented for design control inputs/process procedures to mitigate Single Event Upsets (SEU) or to change design control. * **Management Responsibility:** Executive management failed to ensure an adequate and effective quality system. The Insignia product, with confirmed "no output" failures since 2003, continued distribution without informing users of the potential failure mode or the identified TR 03030 issue, despite approximately 11 explanted devices due to this problem. * **Inadequate Quality Data Analysis:** Failure data from equipment following processes were not routinely collected or analyzed for process monitoring and control. Non-conforming product images from component mounting equipment were not routinely analyzed for quality non-conformances.

**Process Control and