FDA Inspection
Celitron Medical Technologies KftCelitron Medical Technologies Kft – FDA Inspection, Nov 20, 2014
Record Details
This FDA Inspection record concerns Celitron Medical Technologies Kft, with an inspection on November 20, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2014
- Product Type
- Devices
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ID · 7931d03c-5abd-4f79-a173-38f70e8c5c8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 905857
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Celitron Medical Technologies Kft
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Celitron Medical Technologies Kft
- FDA Inspection 1047795 - 2017-12-21
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