SHEIN FULFILLMENT
⚠️ High Risk
FEI: 3027347877 • Zhaoqing • CHINA
FEI Number
3027347877
Location
Zhaoqing
Country
CHINAAddress
Near 255 Township Rd, W, , Zhaoqing, , 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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2025 | 74OFECENTRAL VENOUS BLOOD PRESSURE KIT | Division of Southeast Imports (DSEI) | |
| 3/3/2025 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southeast Imports (DSEI) | |
| 2/21/2025 | 74QYFNEONATAL ICU CONTINUOUS NON-INVASIVE BLOOD PRESSURE MONITOR (INCLUDES ALARMS) | Division of Northern Border Imports (DNBI) | |
| 1/27/2025 | 76KKORING, TEETHING, FLUID-FILLED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/27/2024 | 74OFECENTRAL VENOUS BLOOD PRESSURE KIT | Division of West Coast Imports (DWCI) | |
| 11/12/2024 | 80MEDSTERILANT, MEDICAL DEVICES | Division of Southeast Imports (DSEI) | |
| 9/23/2024 | 74DXQCUFF, BLOOD-PRESSURE | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 9/23/2024 | 73DQAOXIMETER | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 8/16/2024 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 8/16/2024 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 7/25/2024 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 6/12/2024 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 6/6/2024 | 73DQAOXIMETER | Division of West Coast Imports (DWCI) | |
| 4/18/2024 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) | |
| 2/13/2024 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of West Coast Imports (DWCI) |
| 9/22/2023 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHEIN FULFILLMENT's FDA import refusal history?
SHEIN FULFILLMENT (FEI: 3027347877) has 16 FDA import refusal record(s) in our database, spanning from 9/22/2023 to 3/24/2025.
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. SHEIN FULFILLMENT's FEI number is 3027347877.
What types of violations has SHEIN FULFILLMENT received?
SHEIN FULFILLMENT has been cited for 5 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 SHEIN FULFILLMENT come from?
All FDA import refusal data for SHEIN FULFILLMENT 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.