FDA Inspection
Somatics, LLCSomatics, LLC – FDA Inspection, Apr 22, 2016
Record Details
This FDA Inspection record concerns Somatics, LLC, with an inspection on April 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Somatics, LLC
- Inspection Date
- April 22, 2016
- Product Type
- Devices
View Company Profile
ID · 0f2d4e37-016a-4290-9445-6ff9298fbd7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 969948
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Somatics, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | NAI | Florida District Office | Postmarket Assurance: Devices |
| January 25, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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