FDA Inspection
Optovue, Inc.Optovue, Inc. – FDA Inspection, Jan 8, 2010
Record Details
This FDA Inspection record concerns Optovue, Inc., with an inspection on January 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Optovue, Inc.
- Inspection Date
- January 8, 2010
- Product Type
- Devices
View Company Profile
ID · 9184a242-4dba-4ab0-9c18-a2f3340bcee8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 639717
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.25(b)Training
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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 |
| November 15, 2013 | VAI | 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 |
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 795211 - 2012-09-14
- FDA Inspection 716018 - 2011-04-07
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