JINING WONDER TRADING CO LTD
⚠️ Moderate Risk
FEI: 3014434112 • Jining • CHINA
FEI Number
3014434112
Location
Jining
Country
CHINAAddress
No 8 Shengyang Road Eco, , Jining, , 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
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/7/2018 | 65QAP02BOTOX | Division of Southeast Imports (DSEI) | |
| 9/7/2018 | 65QAP02BOTOX | Division of Southeast Imports (DSEI) | |
| 9/7/2018 | 65QAP02BOTOX | Division of Southeast Imports (DSEI) | |
| 9/7/2018 | 65QAP02BOTOX | Division of Southeast Imports (DSEI) | |
| 9/6/2018 | 53PY99OTHER COSMETIC RAW MATERIALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/2/2018 | 65QAP02BOTOX | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/2/2018 | 65QAP02BOTOX | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/2/2018 | 65QAP02BOTOX | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/2/2018 | 65QAP02BOTOX | 71NO LICENSE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JINING WONDER TRADING CO LTD's FDA import refusal history?
JINING WONDER TRADING CO LTD (FEI: 3014434112) has 9 FDA import refusal record(s) in our database, spanning from 8/2/2018 to 9/7/2018.
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. JINING WONDER TRADING CO LTD's FEI number is 3014434112.
What types of violations has JINING WONDER TRADING CO LTD received?
JINING WONDER TRADING CO LTD has been cited for 6 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 JINING WONDER TRADING CO LTD come from?
All FDA import refusal data for JINING WONDER 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.