# FDA 483 - Mirac LLC - February 17, 2026

Source: https://www.keypedia.com/records/483/mirac-llc/144bc26f-6936-4496-88d0-3b48188bcb11

> FDA 483 for Mirac LLC on February 17, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mirac LLC
- Inspection Date: 2026-02-17
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Mirac LLC, a medical device manufacturer in Dayton, OH, received a Form 483 with nine observations following an FDA inspection. The inspection revealed significant deficiencies across its quality management system, including inadequate procedures for nonconforming product control, process validation, risk management, internal audits, supplier control, and document control. These issues indicate a systemic failure to ensure product conformity and maintain an effective quality system.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/mirac-llc/e1da3d0e-1539-49aa-985c-b3c8c5af1dc3

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