San Lian Technology Co Ltd
⚠️ High Risk
FEI: 3010207674 • Tsuen Wantsuen Wan • HONG KONG
FEI Number
3010207674
Location
Tsuen Wantsuen Wan
Country
HONG KONGAddress
Rm 30, 11/F, Thriving Ind. Ctr. No 26-38, , Tsuen Wantsuen Wan, , Hong Kong
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/26/2016 | 28OYY99ESSENTIAL OILS FOR FLAVORING, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/24/2014 | 98C99SMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/28/2014 | 66BBY44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 8/25/2014 | 98A99TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.), BULK | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/31/2014 | 98C99SMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/30/2014 | 66BAY44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 6/30/2014 | 28O99ESSENTIAL OILS FOR FLAVORING, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/23/2014 | 98C99SMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/18/2014 | 66BAY44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 6/17/2014 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/29/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | Los Angeles District Office (LOS-DO) | |
| 5/29/2014 | 98B99CIGARETTES, NOT ELSEWHERE CLASSIFIED (N.E.C.) | Cincinnati District Office (CIN-DO) | |
| 5/29/2014 | 66BAY44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 5/13/2014 | 66BAY44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 4/29/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/14/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/10/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/7/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/31/2014 | 98C99SMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/31/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/31/2014 | 55QY64PROPYLENE GLYCOL (PHARMACEUTIC NECESSITY - SOLVENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/31/2014 | 98C99SMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is San Lian Technology Co Ltd's FDA import refusal history?
San Lian Technology Co Ltd (FEI: 3010207674) has 22 FDA import refusal record(s) in our database, spanning from 3/31/2014 to 2/26/2016.
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. San Lian Technology Co Ltd's FEI number is 3010207674.
What types of violations has San Lian Technology Co Ltd received?
San Lian Technology Co Ltd 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 San Lian Technology Co Ltd come from?
All FDA import refusal data for San Lian Technology 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.