FDA Inspection
Natus Medical Denmark ApSNatus Medical Denmark ApS – FDA Inspection, Jan 12, 2012
Record Details
This FDA Inspection record concerns Natus Medical Denmark ApS, with an inspection on January 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Natus Medical Denmark ApS
- Inspection Date
- January 12, 2012
- Product Type
- Devices
View Company Profile
ID · 32fe34b9-a04b-4261-83ba-f66e4c2c45fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768202
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Natus Medical Denmark ApS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2018 | Not classified | Office of Inspections and Investigations | |
| March 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Natus Medical Denmark ApS
- FDA Inspection 1083892 - 2018-04-19
- FDA Inspection 919049 - 2015-03-12
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