FDA Inspection
COSMED Nordic ApSCOSMED Nordic ApS – FDA Inspection, Oct 26, 2022
Record Details
This FDA Inspection record concerns COSMED Nordic ApS, with an inspection on October 26, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- COSMED Nordic ApS
- Inspection Date
- October 26, 2022
- Product Type
- Devices
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ID · 81bd95ff-661b-4418-91ff-94010e6430ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1182049
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
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Other FDA inspections of COSMED Nordic ApS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2017 | NAI | 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 1022703 - 2017-08-24
- FDA Inspection 850222 - 2013-09-12
- FDA Inspection 772945 - 2012-02-16
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