FDA Inspection
SOMNOmedics AGSOMNOmedics AG – FDA Inspection, May 7, 2015
Record Details
This FDA Inspection record concerns SOMNOmedics AG, with an inspection on May 7, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SOMNOmedics AG
- Inspection Date
- May 7, 2015
- Product Type
- Devices
View Company Profile
ID · b11ab533-852a-4212-a48a-5f6f188bb3fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929266
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SOMNOmedics AG
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2024 | Not classified | Office of Inspections and Investigations | |
| September 13, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 12, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SOMNOmedics AG
- FDA Inspection 1255958 - 2024-09-12
- FDA Inspection 1069974 - 2018-09-13
- FDA Inspection 794229 - 2012-07-12
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