FDA Inspection
Merge Healthcare, Inc.Merge Healthcare, Inc. – FDA Inspection, Aug 12, 2009
Record Details
This FDA Inspection record concerns Merge Healthcare, Inc., with an inspection on August 12, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merge Healthcare, Inc.
- Inspection Date
- August 12, 2009
- Product Type
- Devices
View Company Profile
ID · 92e98dc1-296d-4e15-a1c4-35992c79bf3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605228
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.20(b)(1)Responsibility, authority and independence
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.100(a)(2)Investigation procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Merge Healthcare, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 27, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Merge Healthcare, Inc.
- FDA Inspection 984227 - 2016-08-19
- FDA Inspection 936863 - 2015-07-27
- FDA Inspection 825761 - 2013-03-26
- FDA Inspection 678131 - 2010-08-06
- FDA Inspection 640723 - 2010-01-20
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