Boston Scientific CorporationNovember 26, 2024

FDA 483 - Boston Scientific Corporation - November 26, 2024

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Record Details

Boston Scientific Corporation was inspected and cited for three observations related to quality system deficiencies. The firm failed to adequately establish procedures for design changes and corrective and preventive actions, leading to product issues and recalls. Additionally, the company did not submit a required Medical Device Report within 30 days for a serious device malfunction.

Company: Boston Scientific Corporation
Inspection Date: November 26, 2024
Product Type: Device
Office: New England District Office
Person: Sara M. Onyango

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ID · 3f333115-bd96-40e1-9782-0b2055c37911