FDA Inspection
Mirac LLCMirac LLC – FDA Inspection, Feb 17, 2026
Record Details
This FDA Inspection record concerns Mirac LLC, with an inspection on February 17, 2026, issued by the Cincinnati District Office.
- Company
- Mirac LLC
- Inspection Date
- February 17, 2026
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ID · d1d81b6f-ba9c-428a-91ee-082adb57fd47
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1303200
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.4.1Records of supplier (re)evaluation, selection, and monitoring not maintained
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.1Monitoring, measurement, analysis, and improvement processes not adequate
- ISO 13485:2016 Clause 8.2.4Internal audit procedures not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
- ISO 13485:2016 Clause 4.2.2Specific requirements of the Quality Manual not documented
- ISO 13485:2016 Clause 5.5.1Management responsibilities and authorities not documented
- ISO 13485:2016 Clause 7.2.2Required actions not taken when product requirements changed
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Other FDA inspections of Mirac LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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