Company
United StatesVyaire Medical, Minneapolis, MN – FDA Inspections
Inspection records and compliance data for Vyaire Medical in Minneapolis, Minnesota. 4 FDA inspections on record, last inspected September 30, 2014.
Company Profile
This profile covers Vyaire Medical based in Minneapolis, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected September 18, 2009. Last inspected September 30, 2014.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Document change records, maintained.1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 30, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 899913 |
| September 5, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 801998 |
| November 25, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 754525 |
| September 18, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 614960 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Vyaire Medical
FEI Number
3002617992
Address
17400 Medina Rd Ste 100, Minneapolis, Minnesota 55447, United States
Country
United States
ID: b262e1cf-6312-43e4-b883-b45ebc307a70