FDA Inspection
Symbios Medical Products, LLCSymbios Medical Products, LLC – FDA Inspection, Jun 3, 2013
Record Details
This FDA Inspection record concerns Symbios Medical Products, LLC, with an inspection on June 3, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 3, 2013
- Product Type
- Devices
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ID · c6cfc067-68b2-4bb3-be21-f80a24f23f41
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 834119
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 |
| March 19, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Symbios Medical Products, LLC
- FDA Inspection 1289302 - 2025-10-20
- FDA Inspection 822737 - 2013-03-19
- FDA Inspection 722543 - 2011-04-22
- FDA Inspection 604393 - 2009-08-26
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