FDA Inspection
Aurora Spine IncAurora Spine Inc – FDA Inspection, Sep 18, 2017
Record Details
This FDA Inspection record concerns Aurora Spine Inc, with an inspection on September 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · dee7aa3b-9b34-4b17-ad51-c4412bb345ee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028588
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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Other FDA inspections of Aurora Spine Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 23, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aurora Spine Inc
- FDA Inspection 1063919 - 2018-07-30
- FDA Inspection 881967 - 2014-05-23
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