FDA Inspection
Aerin Medical, Inc.Aerin Medical, Inc. – FDA Inspection, Sep 22, 2025
Record Details
This FDA Inspection record concerns Aerin Medical, Inc., with an inspection on September 22, 2025, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · e30ae416-82d2-4ee3-8cc2-c66d4ad8c89f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1284330
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Aerin Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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