FDA Inspection
Labtician Ophthalmics Inc.Labtician Ophthalmics Inc. – FDA Inspection, Nov 5, 2009
Record Details
This FDA Inspection record concerns Labtician Ophthalmics Inc., with an inspection on November 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Labtician Ophthalmics Inc.
- Inspection Date
- November 5, 2009
- Product Type
- Devices
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ID · 83ab0d17-dea4-4019-a337-c4894465a0a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635209
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of Labtician Ophthalmics Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2018 | Not classified | Office of Inspections and Investigations | |
| July 14, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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