FDA Inspection
Symbios Medical Products, LLCSymbios Medical Products, LLC – FDA Inspection, Apr 22, 2011
Record Details
This FDA Inspection record concerns Symbios Medical Products, LLC, with an inspection on April 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 22, 2011
- Product Type
- Devices
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ID · c111282a-0273-4724-9168-9d0fab5ebd05
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 722543
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.184Lack of or inadequate DHR procedures
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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 |
| 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 834119 - 2013-06-03
- FDA Inspection 822737 - 2013-03-19
- FDA Inspection 604393 - 2009-08-26
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