Company
GermanyRominger Medizintechnik GmbH, Seitingen-Oberflacht, Germany – FDA Inspections
Inspection records and compliance data for Rominger Medizintechnik GmbH in Seitingen-Oberflacht. 2 FDA inspections on record, 1 Form 483, last inspected September 05, 2018.
Company Profile
This profile covers Rominger Medizintechnik GmbH based in Seitingen-Oberflacht, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected December 11, 2013. Last inspected September 5, 2018.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1064786 |
| December 11, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 859242 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Rominger Medizintechnik GmbH
FEI Number
3004207793
Address
Hohnerstr. 22, Seitingen-Oberflacht, Germany
Country
Germany
ID: cf43d615-587a-4703-bea1-64da0b4e8d51