Company
ChinaSuzhou KD Intelligent Device Co., Ltd, Suzhou, China – FDA Inspections
Inspection records and compliance data for Suzhou KD Intelligent Device Co., Ltd in Suzhou. 2 FDA inspections on record, last inspected July 25, 2024.
Company Profile
This profile covers Suzhou KD Intelligent Device Co., Ltd based in Suzhou, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 16, 2016. Last inspected July 25, 2024.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- DHR content1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 25, 2024 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1246231 |
| June 16, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 984322 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Suzhou KD Intelligent Device Co., Ltd
FEI Number
3008466210
Address
No. 36 Gugang Road, Taicang, Suzhou, China
Country
China
ID: 16aff6b1-96d4-4ea2-a69e-1c0c0f62751d