FDA Inspection
Oculus Surgical, Inc.FDA Inspection 660287 - Oculus Surgical, Inc. - May 03, 2010
Record Details
This FDA Inspection record concerns Oculus Surgical, Inc., with an inspection on May 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Oculus Surgical, Inc.
- Inspection Date
- May 3, 2010
- Product Type
- Devices
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ID · 7fab8684-a46c-4e5d-b311-60b742be1069
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 660287
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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 |
| February 17, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 768493 - 2012-02-17
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