Zhenjiang Tianma Craft Lantern
⚠️ Moderate Risk
FEI: 3011806835 • Zhenjiang, Jiangsu • CHINA
FEI Number
3011806835
Location
Zhenjiang, Jiangsu
Country
CHINAAddress
11 West Huangshan Rd, , Zhenjiang, Jiangsu, 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).
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).
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.
Refusal History
Frequently Asked Questions
What is Zhenjiang Tianma Craft Lantern's FDA import refusal history?
Zhenjiang Tianma Craft Lantern (FEI: 3011806835) has 1 FDA import refusal record(s) in our database, spanning from 10/13/2015 to 10/13/2015.
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. Zhenjiang Tianma Craft Lantern's FEI number is 3011806835.
What types of violations has Zhenjiang Tianma Craft Lantern received?
Zhenjiang Tianma Craft Lantern 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 Zhenjiang Tianma Craft Lantern come from?
All FDA import refusal data for Zhenjiang Tianma Craft Lantern 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.