FDA Inspection 1283810 — Mirodx
The FDA completed an inspection of Mirodx on Sep 26, 2025 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |