# FDA 483 - Gauthier Biomedical, Inc. - December 21, 2021

Source: https://www.keypedia.com/records/483/gauthier-biomedical-inc/e565a3ff-9631-43c8-b1c7-3af5c27d6c63

> FDA 483 for Gauthier Biomedical, Inc. on December 21, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gauthier Biomedical, Inc.
- Inspection Date: 2021-12-21
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Gauthier Biomedical, Inc., a medical device manufacturer in Grafton, WI, received a Form FDA-483 with five observations, three of which were repeat observations from a previous inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, MDR event file documentation, process validation, and supplier control. These issues indicate a systemic failure to address quality problems and ensure product conformity.

## Related Officers

- [investigator](https://www.keypedia.com/people/nicholas-t-domer/8e2d2ff5-b0da-4b0d-bd65-492a49ae1035)

Company: https://www.keypedia.com/companies/gauthier-biomedical-inc/bf287207-fc1f-4b2e-963d-3f0c33b1bcec

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