FDA Inspection
XuZhou Kernel Medical Instrument Equipment Co. LtdXuZhou Kernel Medical Instrument Equipment Co. Ltd – FDA Inspection, Nov 12, 2015
Record Details
This FDA Inspection record concerns XuZhou Kernel Medical Instrument Equipment Co. Ltd, with an inspection on November 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 12, 2015
- Product Type
- Devices
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ID · 42dafdb8-2875-4e23-a33e-0b2ecf7306a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955604
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.181DMR - not or inadequately maintained
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Other FDA inspections of XuZhou Kernel Medical Instrument Equipment Co. Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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