FDA Inspection
NordicNeuroLab ASNordicNeuroLab AS – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns NordicNeuroLab AS, with an inspection on June 15, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e16bdea8-ed7f-4364-96a9-b7a3fb5fde54
Inspection Facts
- Inspection number
- 1016002
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 806.10(c)(11)Domestic & foreign consignees
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of NordicNeuroLab AS
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2018 | Not classified | Office of Inspections and Investigations | |
| September 13, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for NordicNeuroLab AS
- FDA Inspection 1105802 - 2018-11-09
- FDA Inspection 798168 - 2012-09-13
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