# FDA 483 - Medtronic Vascular, Inc. - October 15, 2021

Source: https://www.keypedia.com/records/483/medtronic-vascular-inc/59bdcac0-1aa5-4f25-a233-77e9bdfd62f5

> FDA 483 for Medtronic Vascular, Inc. on October 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medtronic Vascular, Inc.
- Inspection Date: 2021-10-15
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Medtronic Vascular, Inc. in Danvers, MA, received a Form FDA 483 with three observations following an inspection. The firm was cited for failing to adequately validate processes, specifically regarding unvalidated release test methods used by a contract manufacturer for pediatric septostomy balloon catheters. Additionally, the inspection revealed inadequate documentation of corrective and preventive actions and a failure to establish proper procedures for ensuring purchased products conform to specified requirements, leading to the acceptance and distribution of non-conforming devices.

## Related Officers

- [Guozhou Mo](https://www.keypedia.com/people/guozhou-mo/5b8f68f4-51f2-4031-9a63-5ea5713109e6)
- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)

Company: https://www.keypedia.com/companies/medtronic-vascular-inc/dd3b0871-062e-4991-99cd-034fd842f885

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94