FDA Inspection
COSMED Nordic ApSCOSMED Nordic ApS – FDA Inspection, Aug 24, 2017
Record Details
This FDA Inspection record concerns COSMED Nordic ApS, with an inspection on August 24, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 6408534a-86b8-4f8d-b36e-5cb4dcedd425
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1022703
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.120(b)Examination for accuracy
- 21 CFR 820.184DHR content
- 21 CFR 820.200(d)Service reports
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of COSMED Nordic ApS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 16, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for COSMED Nordic ApS
- FDA Inspection 1182049 - 2022-10-26
- FDA Inspection 850222 - 2013-09-12
- FDA Inspection 772945 - 2012-02-16
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.