FDA Inspection
Oculus Surgical, Inc.FDA Inspection 916800 - Oculus Surgical, Inc. - February 27, 2015
Record Details
This FDA Inspection record concerns Oculus Surgical, Inc., with an inspection on February 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oculus Surgical, Inc.
- Inspection Date
- February 27, 2015
- Product Type
- Devices
View Company Profile
ID · d9c0e390-a740-4a7f-8b5d-c223e0072500
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916800
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.180Availability
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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 |
| March 1, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 17, 2012 | OAI | 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 820588 - 2013-03-01
- FDA Inspection 768493 - 2012-02-17
- FDA Inspection 660287 - 2010-05-03
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