FDA Inspection
Aurora Optics Company Inc.Aurora Optics Company Inc. – FDA Inspection, Oct 16, 2012
Record Details
This FDA Inspection record concerns Aurora Optics Company Inc., with an inspection on October 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aurora Optics Company Inc.
- Inspection Date
- October 16, 2012
- Product Type
- Devices
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ID · 5d87683c-a6ed-47e7-a17c-3ee605cfd5ca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 803869
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Aurora Optics Company Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aurora Optics Company Inc.
- FDA Inspection 992377 - 2016-11-04
- FDA Inspection 963211 - 2016-02-10
- FDA Inspection 900651 - 2014-10-17
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