FDA Inspection
Optovue, Inc.Optovue, Inc. – FDA Inspection, Sep 14, 2012
Record Details
This FDA Inspection record concerns Optovue, Inc., with an inspection on September 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Optovue, Inc.
- Inspection Date
- September 14, 2012
- Product Type
- Devices
View Company Profile
ID · cf66ba8f-ec8b-43b1-9eec-b548e51ca07a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 795211
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
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 |
| November 15, 2013 | VAI | 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 855282 - 2013-11-15
- FDA Inspection 716018 - 2011-04-07
- FDA Inspection 639717 - 2010-01-08
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