Company
GermanySOMNOmedics AG, Randersacker, Germany – FDA Inspections
Inspection records and compliance data for SOMNOmedics AG in Randersacker. 4 FDA inspections on record, last inspected September 12, 2024.
Company Profile
This profile covers SOMNOmedics AG based in Randersacker, Germany.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected July 12, 2012. Last inspected September 12, 2024.
Most cited issue areas
- DHR content1 inspection
- Documentation1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 12, 2024 | Not classified | Medical Devices & Rad Health | 1255958 |
| September 13, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1069974 |
| May 7, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 929266 |
| July 12, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 794229 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SOMNOmedics AG
FEI Number
3006258337
Address
Am Sonnenstuhl 63, Randersacker, Germany
Country
Germany
ID: 73ec758a-6e21-4b18-aa28-10fe915629d0