FDA Inspection
Aurora Optics Company Inc.Aurora Optics Company Inc. – FDA Inspection, Nov 4, 2016
Record Details
This FDA Inspection record concerns Aurora Optics Company Inc., with an inspection on November 4, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7733d0a9-60b8-4207-8740-6972e358827d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992377
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Aurora Optics Company Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 16, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aurora Optics Company Inc.
- FDA Inspection 963211 - 2016-02-10
- FDA Inspection 900651 - 2014-10-17
- FDA Inspection 803869 - 2012-10-16
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