Shantou Youjia E-Commerce Co., Ltd.
⚠️ Moderate Risk
FEI: 3029934799 • Shantou, Guangdong • CHINA
FEI Number
3029934799
Location
Shantou, Guangdong
Country
CHINAAddress
Huarun Building, Longhu, 95 Changping Road, Shantou, Guangdong, 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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/4/2025 | 76MEFRING, TEETHING, NON-FLUID FILLED | Division of West Coast Imports (DWCI) | |
| 7/10/2024 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shantou Youjia E-Commerce Co., Ltd.'s FDA import refusal history?
Shantou Youjia E-Commerce Co., Ltd. (FEI: 3029934799) has 3 FDA import refusal record(s) in our database, spanning from 7/10/2024 to 7/21/2025.
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. Shantou Youjia E-Commerce Co., Ltd.'s FEI number is 3029934799.
What types of violations has Shantou Youjia E-Commerce Co., Ltd. received?
Shantou Youjia E-Commerce Co., Ltd. has been cited for 4 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 Shantou Youjia E-Commerce Co., Ltd. come from?
All FDA import refusal data for Shantou Youjia E-Commerce 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.