# FDA 483 - Mainstay Medical Limited US, Inc. - December 20, 2019

Source: https://www.keypedia.com/records/483/mainstay-medical-limited-us-inc/35b3e86e-80ee-49f5-a07a-e9f3c04ae55d

> FDA 483 for Mainstay Medical Limited US, Inc. on December 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mainstay Medical Limited US, Inc.
- Inspection Date: 2019-12-20
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Mainstay Medical Limited US, Inc. in Minneapolis, MN, was cited for deficiencies as a sponsor of an investigational device study. The inspection revealed failures in submitting timely annual progress reports to IRBs and widespread issues in ensuring proper monitoring of the investigational study. These observations indicate a lack of adherence to regulatory requirements for clinical trial oversight and reporting.

## Related Officers

- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.keypedia.com/companies/mainstay-medical-limited-us-inc/388b4bdd-fc55-41fd-b7d6-be304c73b5ae

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