Company
ChinaPARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD., Changzhou, China – FDA Inspections
Inspection records and compliance data for PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. in Changzhou. 3 FDA inspections on record, 2 Form 483s, last inspected June 26, 2025.
Company Profile
This profile covers PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. based in Changzhou, China.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected May 16, 2013. Last inspected June 26, 2025.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Environmental control Lack of or inadequate procedures1 inspection
- Quality audits - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 26, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1275470 |
| October 27, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 992391 |
| May 16, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 834494 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.
FEI Number
3007539489
Address
Gdh Industrial Park 3A, NO. 16 Chuangye Road; Xinbei, Changzhou, China
Country
China
ID: 55417a9e-6b13-4ba9-ab19-325be34b3688