FDA Inspection
Symbios Medical Products, LLCSymbios Medical Products, LLC – FDA Inspection, Aug 26, 2009
Record Details
This FDA Inspection record concerns Symbios Medical Products, LLC, with an inspection on August 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 26, 2009
- Product Type
- Devices
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ID · e440590d-81f3-43a1-b0f9-838f380ff383
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 604393
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - simulated testing
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Other FDA inspections of Symbios Medical Products, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Symbios Medical Products, LLC
- FDA Inspection 1289302 - 2025-10-20
- FDA Inspection 834119 - 2013-06-03
- FDA Inspection 822737 - 2013-03-19
- FDA Inspection 722543 - 2011-04-22
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