Company
GermanySomatex Medical Technologies GMBH, Berlin, Germany – FDA Inspections
Inspection records and compliance data for Somatex Medical Technologies GMBH in Berlin. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected November 06, 2019.
Company Profile
This profile covers Somatex Medical Technologies GMBH based in Berlin, Germany.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected October 16, 2014. Last inspected November 6, 2019.
Most cited issue areas
- Documentation1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 6, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1108917 |
| September 10, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 941408 |
| October 16, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 899832 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Somatex Medical Technologies GMBH
FEI Number
1000408433
Address
Hohenzollerndamm 150-151, Berlin, Germany
Country
Germany
ID: 5225948d-3741-46de-9643-9571e652d5ed