FDA Inspection
Control-X Medical Zrt.Control-X Medical Zrt. – FDA Inspection, Aug 10, 2023
Record Details
This FDA Inspection record concerns Control-X Medical Zrt., with an inspection on August 10, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cc2a3eca-66a3-412f-9b48-a781341e98f4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1214578
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.86Acceptance status
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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