Company
SwedenMaquet Critical Care AB, Solna, Sweden – FDA Inspections
Inspection records and compliance data for Maquet Critical Care AB in Solna. 2 FDA inspections on record (1 OAI), 1 Form 483, last inspected September 26, 2019.
Company Profile
This profile covers Maquet Critical Care AB based in Solna, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected September 13, 2013. Last inspected September 26, 2019.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 26, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1102876 |
| September 13, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 854366 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Maquet Critical Care AB
FEI Number
3002808128
Address
Rontgenvagen 2, Solna, Sweden
Country
Sweden
ID: e980d230-7ce0-46c7-bb5d-075d244e6cfb