FDA Inspection
Suzhou KD Intelligent Device Co., LtdSuzhou KD Intelligent Device Co., Ltd – FDA Inspection, Jul 25, 2024
Record Details
This FDA Inspection record concerns Suzhou KD Intelligent Device Co., Ltd, with an inspection on July 25, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1c067f21-2a91-48e1-bb74-d9f7b44b2b3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1246231
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.80(c)Documentation
- 21 CFR 801.20(a)Label to bear a unique device identifier
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Other FDA inspections of Suzhou KD Intelligent Device Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Suzhou KD Intelligent Device Co., Ltd
- FDA Inspection 984322 - 2016-06-16
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