FDA Inspection
Ocular Concepts LLCOcular Concepts LLC – FDA Inspection, Dec 5, 2012
Record Details
This FDA Inspection record concerns Ocular Concepts LLC, with an inspection on December 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ocular Concepts LLC
- Inspection Date
- December 5, 2012
- Product Type
- Devices
View Company Profile
ID · 67b08259-7317-4cb6-88ea-9c771bb4519a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 808747
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ocular Concepts LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ocular Concepts LLC
- FDA Inspection 916820 - 2015-02-26
- FDA Inspection 582904 - 2009-05-20
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