# FDA 483 - Boston Scientific Corporation - November 26, 2024

Source: https://www.keypedia.com/records/483/boston-scientific-corporation/3f333115-bd96-40e1-9782-0b2055c37911

> FDA 483 for Boston Scientific Corporation on November 26, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Scientific Corporation
- Inspection Date: 2024-11-26
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/boston-scientific-corporation/7b03f40b-d516-4bcb-9702-929c6f485000

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144