Company
DenmarkNatus Medical Denmark ApS, Taastrup, Denmark – FDA Inspections
Inspection records and compliance data for Natus Medical Denmark ApS in Taastrup. 3 FDA inspections on record, 1 Form 483, last inspected April 19, 2018.
Company Profile
This profile covers Natus Medical Denmark ApS based in Taastrup, Denmark.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 12, 2012. Last inspected April 19, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation - user needs and intended uses1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 19, 2018 | Not classified | Medical Devices & Rad Health | 1083892 |
| March 12, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 919049 |
| January 12, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 768202 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Natus Medical Denmark ApS
FEI Number
3002807554
Address
Horskatten 9, Taastrup, Denmark
Country
Denmark
ID: 61a18d39-7f92-40a9-8057-135fb44ad96a