FDA Inspection
Z-SYSTEMS AGZ-SYSTEMS AG – FDA Inspection, Apr 25, 2024
Record Details
This FDA Inspection record concerns Z-SYSTEMS AG, with an inspection on April 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2d7632b4-c5d5-4d94-b77b-ef2fd3d88187
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1236842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Z-SYSTEMS AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Z-SYSTEMS AG
- FDA Inspection 799433 - 2012-09-13
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