FDA Inspection
Visicu, Inc.Visicu, Inc. – FDA Inspection, Apr 19, 2016
Record Details
This FDA Inspection record concerns Visicu, Inc., with an inspection on April 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Visicu, Inc.
- Inspection Date
- April 19, 2016
- Product Type
- Devices
View Company Profile
ID · 2fe29a86-f5d3-498f-b78a-04e6a639c83d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967251
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Visicu, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 28, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Visicu, Inc.
- FDA Inspection 918446 - 2015-04-13
- FDA Inspection 764115 - 2012-01-11
- FDA Inspection 614583 - 2009-09-28
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