Company
United StatesOculus Surgical, Inc. - Inspection Records
Inspection records and compliance data for Oculus Surgical, Inc. in Stuart, Florida. 5 FDA inspections on record (1 OAI), last inspected December 11, 2017.
Company Profile
This profile covers Oculus Surgical, Inc. based in Stuart, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected May 3, 2010. Last inspected December 11, 2017.
Most cited issue areas
- Documentation2 inspections
- Investigation of device failures2 inspections
- Lack of or inadequate process validation2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1034626 |
| February 27, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 916800 |
| March 1, 2013 | NAI | Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 820588 |
| February 17, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 768493 |
| May 3, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 660287 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Oculus Surgical, Inc.
FEI Number
1052234
Address
2580 Se Willoughby Blvd, Stuart, Florida 34994, United States
Country
United States
ID: 02bec6cc-18ae-46ce-b2a7-65c3e0d83472