Company
AustriaSafersonic Medizinprodukte Handelsges MBH, Persenbeug-Gottsdorf, Austria – FDA Inspections
Inspection records and compliance data for Safersonic Medizinprodukte Handelsges MBH in Persenbeug-Gottsdorf. 1 FDA inspection on record (1 OAI), 1 Form 483, last inspected March 22, 2023.
Company Profile
This profile covers Safersonic Medizinprodukte Handelsges MBH based in Persenbeug-Gottsdorf, Austria.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected March 22, 2023.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 22, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1201606 |
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
Safersonic Medizinprodukte Handelsges MBH
FEI Number
3008177921
Address
Hauptstrase 16/2, Persenbeug-Gottsdorf, Austria
Country
Austria
ID: 9a2dd515-a2b6-48b3-9f18-eb7caf4318a2