FDA Inspection
Oculus Surgical, Inc.FDA Inspection 768493 - Oculus Surgical, Inc. - February 17, 2012
Record Details
This FDA Inspection record concerns Oculus Surgical, Inc., with an inspection on February 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oculus Surgical, Inc.
- Inspection Date
- February 17, 2012
- Product Type
- Devices
View Company Profile
ID · fad76235-47f6-48de-8ed7-1e6e99a35395
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 768493
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oculus Surgical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 27, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 1, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 3, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Oculus Surgical, Inc.
- FDA Inspection 1034626 - 2017-12-11
- FDA Inspection 916800 - 2015-02-27
- FDA Inspection 820588 - 2013-03-01
- FDA Inspection 660287 - 2010-05-03
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