# FDA 483 - Boston Scientific Corporation - January 11, 2017

Source: https://www.globalkeysolutions.net/records/483/boston-scientific-corporation/941df74c-8d96-4cf9-9b26-0fe623c650e1

> FDA 483 for Boston Scientific Corporation on January 11, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston Scientific Corporation
- Inspection Date: 2017-01-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Boston Scientific Corporation in Fremont, CA, revealed significant quality system deficiencies related to their Angiolet Thrombectomy System. The firm failed to report device corrections to the FDA, adequately establish corrective and preventive action procedures, and properly investigate complaints regarding device malfunctions. These issues primarily concerned sticking foot pedals, indicating a lack of robust quality control and potential risks to patient safety.

## Related Officers

- [Founder and Chief Executive Officer](https://www.globalkeysolutions.net/people/adam-s-freeman/8bbc5e50-32c6-4559-b5c9-01b88d102450)

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/9b29de5f-6e81-49c8-9774-21101b95dcd9

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b