# Enterra Medical, Inc. – FDA 483, May 4, 2026

Source: https://www.keypedia.com/records/483/enterra-medical-inc/5a688bf3-830b-458c-9759-21599ec5deeb

> FDA 483 for Enterra Medical, Inc. on May 04, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enterra Medical, Inc.
- Inspection Date: 2026-05-04
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Enterra Medical, Inc. in St. Louis Park, MN, received five observations during an FDA inspection concerning its Class III medical device for chronic nausea and vomiting. The inspection revealed significant deficiencies in process validation, risk management documentation and implementation, the application of risk-based quality management, evaluation of design changes, and supplier management. These issues indicate systemic problems in the firm's quality system that could impact device safety and effectiveness.

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/enterra-medical-inc/6b8b47b0-0b59-4192-bb09-da8ae0d77fbf

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