# FDA 483 - Guardian Medical USA Inc. - June 02, 2026

Source: https://www.keypedia.com/records/483/guardian-medical-usa-inc/a22db704-8c57-4324-8558-712cdb9ee97d

> FDA 483 for Guardian Medical USA Inc. on June 02, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guardian Medical USA Inc.
- Inspection Date: 2026-06-02
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Guardian Medical USA Inc. in Swanton, OH, was inspected and cited for significant deficiencies across its quality management system. The inspection revealed inadequate documentation for design transfer, process validation, risk management, nonconforming product control, supplier evaluation, and corrective action procedures. These issues indicate a systemic failure to establish and follow robust quality processes for medical device manufacturing.

## Related Officers

- [investigator](https://www.keypedia.com/people/felicia-e-armbrustmacher/83e0f3f7-2bfc-4250-8627-76685eee6b03)

Company: https://www.keypedia.com/companies/guardian-medical-usa-inc/cc973eb8-b4e0-4b77-837e-0e72c3b13a23

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22