# FDA 483 - Mirodx - September 26, 2025

Source: https://www.globalkeysolutions.net/records/483/mirodx/9cc16146-8461-4a30-8594-8089dd87e05a

> FDA 483 for Mirodx on September 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mirodx
- Inspection Date: 2025-09-26
- Product Type: device
- Office Name: Dallas District Office
- Summary: Mirodx, a medical device manufacturer in Dallas, TX, was issued a Form 483 with three observations following an FDA inspection. The firm failed to conduct adequate risk analyses for its Class II VERIS CareKits and exhibited deficiencies in establishing and maintaining records for acceptable suppliers, including missing onsite audits. Additionally, internal quality audits were not conducted by individuals independent of the areas being audited, indicating significant quality system concerns.

## Related Officers

- [Katherine M. Thames](https://www.globalkeysolutions.net/people/katherine-m-thames/06a4ece2-7417-42d5-93ab-d744aa5279eb)
- [Katlin N. Stubbs](https://www.globalkeysolutions.net/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)

Company: https://www.globalkeysolutions.net/companies/mirodx/32dd43f8-f43f-4cc4-9d4e-6df9bf2dfce1

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9