FDA Inspection
Advanced Bionics, LLCAdvanced Bionics, LLC – FDA Inspection, Sep 28, 2018
Record Details
This FDA Inspection record concerns Advanced Bionics, LLC, with an inspection on September 28, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5c9076d5-dea3-4585-94ca-2596e47bcb84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1067389
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Advanced Bionics, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 8, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 23, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Advanced Bionics, LLC
- FDA Inspection 1090274 - 2019-05-08
- FDA Inspection 943363 - 2015-09-23
- FDA Inspection 832131 - 2013-05-16
- FDA Inspection 778606 - 2012-04-26
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