Company
SwitzerlandZ-SYSTEMS AG, Oensingen, Switzerland – FDA Inspections
Inspection records and compliance data for Z-SYSTEMS AG in Oensingen. 2 FDA inspections on record (1 OAI), last inspected April 25, 2024.
Company Profile
This profile covers Z-SYSTEMS AG based in Oensingen, Switzerland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 13, 2012. Last inspected April 25, 2024.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- Evaluation, timeliness, identification1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 25, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1236842 |
| September 13, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 799433 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Z-SYSTEMS AG
FEI Number
3006948427
Address
Werkhofstrasse 5, Oensingen, Switzerland
Country
Switzerland
ID: a97bbdb8-0fac-4b1e-b8bf-be03b0c74e1b