Company
ChinaJKH Health Co., Ltd, Dongguan, China – FDA Inspections
Inspection records and compliance data for JKH Health Co., Ltd in Dongguan. 4 FDA inspections on record, 3 Form 483s, last inspected October 31, 2024.
Company Profile
This profile covers JKH Health Co., Ltd based in Dongguan, China.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected November 6, 2014. Last inspected October 31, 2024.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 31, 2024 | Not classified | Medical Devices & Rad Health · Product Evaluation: Medical Devices | 1253982 |
| July 27, 2023 | Not classified | Medical Devices & Rad Health | 1215642 |
| February 8, 2018 | Not classified | Medical Devices & Rad Health | 1042808 |
| November 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 905697 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
JKH Health Co., Ltd
FEI Number
3009437400
Address
Building 14 F 3-5 F 11, And; Changanzhen Changanzhen, Dongguan, China
Country
China
ID: 7ef52581-9635-4948-968c-c93b96687c4f