Changzhou Kangdi Medical Stapler Co., Ltd
✅ Low Risk
FEI: 3008395038 • Changzhou, Jiangsu • CHINA
FEI Number
3008395038
Location
Changzhou, Jiangsu
Country
CHINAAddress
No 16 Kunlun Road, Xinbei District, Changzhou, Jiangsu, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2014 | 79GDWSTAPLE, IMPLANTABLE | 3741FRNMFGREG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Changzhou Kangdi Medical Stapler Co., Ltd's FDA import refusal history?
Changzhou Kangdi Medical Stapler Co., Ltd (FEI: 3008395038) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2014 to 1/16/2014.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Changzhou Kangdi Medical Stapler Co., Ltd's FEI number is 3008395038.
What types of violations has Changzhou Kangdi Medical Stapler Co., Ltd received?
Changzhou Kangdi Medical Stapler Co., Ltd has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Changzhou Kangdi Medical Stapler Co., Ltd come from?
All FDA import refusal data for Changzhou Kangdi Medical Stapler Co., Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.