FDA Inspection 1313766 — Somatics, LLC
The FDA completed an inspection of Somatics, LLC on April 24, 2026 in Venice, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: 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 |