Company
United StatesOptovue, Inc., Fremont, CA – FDA Inspections
Inspection records and compliance data for Optovue, Inc. in Fremont, California. 6 FDA inspections on record (2 OAI), last inspected March 20, 2017.
Company Profile
This profile covers Optovue, Inc. based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 8, 2010. Last inspected March 20, 2017.
Most cited issue areas
- Design control - no procedures1 inspection
- Design validation - software validation not performed1 inspection
- Design verification procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 20, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1006623 |
| April 14, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 982436 |
| November 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 855282 |
| September 14, 2012 | OAI | Medical Devices & Rad Health · Compliance: Devices | 795211 |
| April 7, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 716018 |
| January 8, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 639717 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Optovue, Inc.
FEI Number
3005950902
Address
2800 Bayview Dr, Fremont, California 94538, United States
Country
United States
ID: 4bd8cfe7-d0f3-4543-87c1-b45a72a966b8