# FDA 483 - Boston Scientific Corporation - November 16, 2018

Source: https://www.globalkeysolutions.net/records/483/boston-scientific-corporation/a4dcdaf7-9727-41af-b03e-b1a4a97f7265

> FDA 483 for Boston Scientific Corporation on November 16, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Boston Scientific Corporation
- Inspection Date: 2018-11-16
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Boston Scientific Corporation in Maple Grove, MN, identified significant issues in the management of an investigational clinical study. The firm's PMA Clinical Study Report records were found to be inaccurate and incomplete, with numerous unreported safety events and protocol deviations. Furthermore, proper monitoring of clinical study sites was not ensured, leading to unaddressed non-compliances and a failure to secure investigator compliance.

## Related Documents

- [483 - 2005-08-25](https://www.globalkeysolutions.net/records/483/boston-scientific-corporation/82d11ee7-fb79-4df5-b540-9eec7d10e8ff)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sharon-l-matson/1d2e6d91-1d00-455d-a2e6-a73b1c6b82cc)

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/6ffb7cb5-f8b3-496e-af54-edc0cd74487e

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d