FDA Inspection 1313766 — Somatics, LLC
The FDA completed an inspection of Somatics, LLC on April 24, 2026 in Venice, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Venice, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23101 | ISO 13485:2016 Clause 7.3.2 | Design and development planning documentation not adequate |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |