Company
United StatesVisicu, Inc., Baltimore, MD – FDA Inspections
Inspection records and compliance data for Visicu, Inc. in Baltimore, Maryland. 4 FDA inspections on record, last inspected April 19, 2016.
Company Profile
This profile covers Visicu, Inc. based in Baltimore, Maryland, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 28, 2009. Last inspected April 19, 2016.
Most cited issue areas
- Design input - Lack of or inadequate procedures2 inspections
- Design verification - Lack of or inadequate procedures2 inspections
- Individual Report of Malfunction2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 19, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 967251 |
| April 13, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 918446 |
| January 11, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 764115 |
| September 28, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 614583 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Visicu, Inc.
FEI Number
3003063823
Address
217 E Redwood St Ste 1900, Baltimore, Maryland 21202, United States
Country
United States
ID: 5106f8fe-ca1d-4a58-bf13-52483b36766b