Changshu Yushan Protection Products Co. Ltd.
⚠️ High Risk
FEI: 3008322394 • Suzhou, Jiangsu • CHINA
FEI Number
3008322394
Location
Suzhou, Jiangsu
Country
CHINAAddress
Building #1, Sect. A, Ma-Qiao Indus. Sq., ;Tongganglu; Changshu, Suzhou, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2025 | 86HQCUNIT, PHACOFRAGMENTATION | Division of Southwest Imports (DSWI) | |
| 10/10/2025 | 80KKXDRAPE, SURGICAL | Division of Southwest Imports (DSWI) | |
| 10/10/2025 | 80KKXDRAPE, SURGICAL | Division of Southwest Imports (DSWI) | |
| 10/10/2025 | 80KKXDRAPE, SURGICAL | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Changshu Yushan Protection Products Co. Ltd.'s FDA import refusal history?
Changshu Yushan Protection Products Co. Ltd. (FEI: 3008322394) has 4 FDA import refusal record(s) in our database, spanning from 10/10/2025 to 12/11/2025.
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. Changshu Yushan Protection Products Co. Ltd.'s FEI number is 3008322394.
What types of violations has Changshu Yushan Protection Products Co. Ltd. received?
Changshu Yushan Protection Products Co. Ltd. has been cited for 2 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 Changshu Yushan Protection Products Co. Ltd. come from?
All FDA import refusal data for Changshu Yushan Protection Products 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.