SHENZHEN HEJIA TRADING CO., LTD.
⚠️ Moderate Risk
FEI: 3015244691 • Shenzhen • CHINA
FEI Number
3015244691
Location
Shenzhen
Country
CHINAAddress
429 Fude Building, Huaidian Xiantian, , 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.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 8/23/2024 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 1/24/2022 | 76EBFMATERIAL, TOOTH SHADE, RESIN | Division of Southeast Imports (DSEI) | |
| 4/27/2021 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN HEJIA TRADING CO., LTD.'s FDA import refusal history?
SHENZHEN HEJIA TRADING CO., LTD. (FEI: 3015244691) has 3 FDA import refusal record(s) in our database, spanning from 4/27/2021 to 8/23/2024.
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 HEJIA TRADING CO., LTD.'s FEI number is 3015244691.
What types of violations has SHENZHEN HEJIA TRADING CO., LTD. received?
SHENZHEN HEJIA TRADING 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 SHENZHEN HEJIA TRADING CO., LTD. come from?
All FDA import refusal data for SHENZHEN HEJIA TRADING 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.