Company
ChinaHenan Kangdi Medical Devices Co. Ltd, Zhoukou, China – FDA Inspections
Inspection records and compliance data for Henan Kangdi Medical Devices Co. Ltd in Zhoukou. 2 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected March 07, 2019.
Company Profile
This profile covers Henan Kangdi Medical Devices Co. Ltd based in Zhoukou, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 1
First inspected December 14, 2016. Last inspected March 7, 2019.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Batch production and Batch Control Record Requirements1 inspection
- Buildings not maintained in good state of repair1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1084134 |
| December 14, 2016 | VAI | Human Drugs · Drug Quality Assurance | 995883 |
FDA documents
Form 483s (1)
Warning Letters (1)
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Company Information
Name
Henan Kangdi Medical Devices Co. Ltd
FEI Number
3009271465
Address
Sme Pioneer Park, No. 4 2nd Area, Zhoukou, China
Country
China
ID: 27cc9024-4259-4761-bbf2-9c1bf3ddb827