483
Boston Scientific CorporationBoston Scientific Corporation – FDA 483, Nov 26, 2024
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.
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ID · 3f333115-bd96-40e1-9782-0b2055c37911
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