Shenzhen Yudayuan Trade, Ltd.
⚠️ Moderate Risk
FEI: 3009349291 • Shenzhen • CHINA
FEI Number
3009349291
Location
Shenzhen
Country
CHINAAddress
708 Yuyuangxincun Longchen Town, , Shenzhen, , China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/7/2018 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 12/7/2018 | 53IH99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shenzhen Yudayuan Trade, Ltd.'s FDA import refusal history?
Shenzhen Yudayuan Trade, Ltd. (FEI: 3009349291) has 2 FDA import refusal record(s) in our database, spanning from 12/7/2018 to 12/7/2018.
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. Shenzhen Yudayuan Trade, Ltd.'s FEI number is 3009349291.
What types of violations has Shenzhen Yudayuan Trade, Ltd. received?
Shenzhen Yudayuan Trade, Ltd. has been cited for 3 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 Shenzhen Yudayuan Trade, Ltd. come from?
All FDA import refusal data for Shenzhen Yudayuan Trade, 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.