FDA Inspection
Visicu, Inc.Visicu, Inc. – FDA Inspection, Apr 13, 2015
Record Details
This FDA Inspection record concerns Visicu, Inc., with an inspection on April 13, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Visicu, Inc.
- Inspection Date
- April 13, 2015
- Product Type
- Devices
View Company Profile
ID · db9b1613-892a-4857-8065-1826dc9be2d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918446
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 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(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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 |
| 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 967251 - 2016-04-19
- FDA Inspection 764115 - 2012-01-11
- FDA Inspection 614583 - 2009-09-28
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