FDA Inspection
Optovue, Inc.Optovue, Inc. – FDA Inspection, Nov 15, 2013
Record Details
This FDA Inspection record concerns Optovue, Inc., with an inspection on November 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Optovue, Inc.
- Inspection Date
- November 15, 2013
- Product Type
- Devices
View Company Profile
ID · b3f2955b-faba-48b7-b99f-e4f5d51d973b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855282
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no 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 Optovue, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 14, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 7, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 8, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Optovue, Inc.
- FDA Inspection 1006623 - 2017-03-20
- FDA Inspection 982436 - 2016-04-14
- FDA Inspection 795211 - 2012-09-14
- FDA Inspection 716018 - 2011-04-07
- FDA Inspection 639717 - 2010-01-08
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