FDA Inspection
Somatics, LLCSomatics, LLC – FDA Inspection, Jan 25, 2012
Record Details
This FDA Inspection record concerns Somatics, LLC, with an inspection on January 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Somatics, LLC
- Inspection Date
- January 25, 2012
- Product Type
- Devices
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ID · d87e2c80-d471-428f-b031-9e998bf0676b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767481
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 820.80(e)Documentation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Somatics, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | NAI | Florida District Office | Postmarket Assurance: Devices |
| April 22, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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