SHANTOU CROSS-BORDER
⚠️ High Risk
FEI: 3026915584 • Shantou, Guangdong • CHINA
FEI Number
3026915584
Location
Shantou, Guangdong
Country
CHINAAddress
Rm 5, Bldg 5 Bldg 1901 Century Business Ctr, Shantou, Guangdong, 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
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).
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 |
|---|---|---|---|
| 6/10/2025 | 79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT | Division of Southeast Imports (DSEI) | |
| 3/3/2025 | 65LBY02ALLANTOIN (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/3/2025 | 64XAY06SALICYLIC ACID (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2024 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2023 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/15/2023 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 4/24/2023 | 62MBY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHANTOU CROSS-BORDER's FDA import refusal history?
SHANTOU CROSS-BORDER (FEI: 3026915584) has 7 FDA import refusal record(s) in our database, spanning from 4/24/2023 to 6/10/2025.
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 CROSS-BORDER's FEI number is 3026915584.
What types of violations has SHANTOU CROSS-BORDER received?
SHANTOU CROSS-BORDER 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 CROSS-BORDER come from?
All FDA import refusal data for SHANTOU CROSS-BORDER 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.