SHENZHEN DIDUO ARTS AND CRAFTS CO LTD
✅ Low Risk
FEI: 3013842942 • Guangming New District • CHINA
FEI Number
3013842942
Location
Guangming New District
Country
CHINAAddress
No. 88 Nanzhi Lane, The 4th Row, Xiacun Vi, Shenzhen Gongming Town, Guangming New District, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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.
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
Frequently Asked Questions
What is SHENZHEN DIDUO ARTS AND CRAFTS CO LTD's FDA import refusal history?
SHENZHEN DIDUO ARTS AND CRAFTS CO LTD (FEI: 3013842942) has 1 FDA import refusal record(s) in our database, spanning from 11/12/2021 to 11/12/2021.
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 DIDUO ARTS AND CRAFTS CO LTD's FEI number is 3013842942.
What types of violations has SHENZHEN DIDUO ARTS AND CRAFTS CO LTD received?
SHENZHEN DIDUO ARTS AND CRAFTS CO LTD has been cited for 3 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 DIDUO ARTS AND CRAFTS CO LTD come from?
All FDA import refusal data for SHENZHEN DIDUO ARTS AND CRAFTS 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.