FDA Inspection 1303200 — Mirac LLC
The FDA completed an inspection of Mirac LLC on February 17, 2026 in Dayton, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 17, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dayton, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23034 | ISO 13485:2016 Clause 4.2.2 | Specific requirements of the Quality Manual not documented |
| 23055 | ISO 13485:2016 Clause 5.5.1 | Management responsibilities and authorities not documented |
| 23096 | ISO 13485:2016 Clause 7.2.2 | Required actions not taken when product requirements changed |
| 23145 | ISO 13485:2016 Clause 7.4.1 | Records of supplier (re)evaluation, selection, and monitoring not maintained |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23208 | ISO 13485:2016 Clause 8.1 | Monitoring, measurement, analysis, and improvement processes not adequate |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |
| 23237 | ISO 13485:2016 Clause 8.3.1 | Procedure for nonconforming product not documented |