FDA Inspection
Southwest Artificial Eyes, IncSouthwest Artificial Eyes, Inc – FDA Inspection, Mar 23, 2017
Record Details
This FDA Inspection record concerns Southwest Artificial Eyes, Inc, with an inspection on March 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9567d19-52bc-47c9-8b3f-7add241fc512
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1018971
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Southwest Artificial Eyes, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 8, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Southwest Artificial Eyes, Inc
- FDA Inspection 771116 - 2012-03-08
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