FDA Inspection
Somatics, LLCSomatics, LLC – FDA Inspection, Apr 24, 2026
Record Details
This FDA Inspection record concerns Somatics, LLC, with an inspection on April 24, 2026, issued by the Florida District Office, covering medical devices & rad health.
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ID · 885cf84e-ea62-41b6-857f-432e8549d6cb
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1313766
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.3.2Design and development planning documentation not adequate
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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Other FDA inspections of Somatics, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 25, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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