FDA Inspection
Novus Scientific AbNovus Scientific Ab – FDA Inspection, Mar 12, 2015
Record Details
This FDA Inspection record concerns Novus Scientific Ab, with an inspection on March 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Novus Scientific Ab
- Inspection Date
- March 12, 2015
- Product Type
- Devices
View Company Profile
ID · 92fc00cb-5df0-4a2f-91b9-c1d7bd55a8f1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918032
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 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 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Novus Scientific Ab
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2025 | Not classified | Office of Inspections and Investigations | |
| October 24, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Novus Scientific Ab
- FDA Inspection 1265378 - 2025-01-23
- FDA Inspection 1031294 - 2017-10-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.