FDA Inspection
Visicu, Inc.Visicu, Inc. – FDA Inspection, Sep 28, 2009
Record Details
This FDA Inspection record concerns Visicu, Inc., with an inspection on September 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Visicu, Inc.
- Inspection Date
- September 28, 2009
- Product Type
- Devices
View Company Profile
ID · d53fef66-a4bb-4c3e-ac10-65bdf064c5eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 614583
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(i)Documentation of software validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Visicu, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Visicu, Inc.
- FDA Inspection 967251 - 2016-04-19
- FDA Inspection 918446 - 2015-04-13
- FDA Inspection 764115 - 2012-01-11
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