Union Chance Co Ltd
⚠️ Moderate Risk
FEI: 3009692857 • Yiwu • CHINA
FEI Number
3009692857
Location
Yiwu
Country
CHINAAddress
1f 200# North Zongze Road, , Yiwu, , 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/12/2012 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/12/2012 | 53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C. | 471CSTIC LBLG | Minneapolis District Office (MIN-DO) |
| 9/12/2012 | 76NXZKIT, DENTAL HYGIENE | Minneapolis District Office (MIN-DO) | |
| 9/12/2012 | 76NXZKIT, DENTAL HYGIENE | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Union Chance Co Ltd's FDA import refusal history?
Union Chance Co Ltd (FEI: 3009692857) has 4 FDA import refusal record(s) in our database, spanning from 9/12/2012 to 9/12/2012.
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. Union Chance Co Ltd's FEI number is 3009692857.
What types of violations has Union Chance Co Ltd received?
Union Chance 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 Union Chance Co Ltd come from?
All FDA import refusal data for Union Chance 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.