SHANGHAI DAKING TRADE COMPANY LTD
⚠️ Moderate Risk
FEI: 3030085862 • Jia Ding District, Shanghai • CHINA
FEI Number
3030085862
Location
Jia Ding District, Shanghai
Country
CHINAAddress
Room 0032, No. 2585 Huyi Highway, Jia Ding District, Shanghai, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | Division of West Coast Imports (DWCI) | |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/18/2025 | 79ERYDRAPE, SURGICAL, ENT | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SHANGHAI DAKING TRADE COMPANY LTD's FDA import refusal history?
SHANGHAI DAKING TRADE COMPANY LTD (FEI: 3030085862) has 4 FDA import refusal record(s) in our database, spanning from 7/18/2025 to 7/18/2025.
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. SHANGHAI DAKING TRADE COMPANY LTD's FEI number is 3030085862.
What types of violations has SHANGHAI DAKING TRADE COMPANY LTD received?
SHANGHAI DAKING TRADE COMPANY LTD has been cited for 2 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 SHANGHAI DAKING TRADE COMPANY LTD come from?
All FDA import refusal data for SHANGHAI DAKING TRADE COMPANY 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.