Schenzhen Smoore Technology Limited
⚠️ Moderate Risk
FEI: 3007471654 • Shenzhen, Guangdong • CHINA
FEI Number
3007471654
Location
Shenzhen, Guangdong
Country
CHINAAddress
Building 1th F/6, Baoan, Shenzhen, Guangdong, 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2020 | 98MAA07ENDS CARTRIDGE | Division of Southeast Imports (DSEI) | |
| 8/17/2009 | 77KCOINHALER, NASAL | Cincinnati District Office (CIN-DO) | |
| 8/17/2009 | 66BBY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/29/2009 | 80MSNCIGARETTES (CONTAINING TOBACCO) | Seattle District Office (SEA-DO) | |
| 7/16/2009 | 77KCOINHALER, NASAL | Cincinnati District Office (CIN-DO) | |
| 6/23/2009 | 80MSNCIGARETTES (CONTAINING TOBACCO) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/23/2009 | 66BCY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/5/2009 | 77KCOINHALER, NASAL | 237NO PMA | Cincinnati District Office (CIN-DO) |
| 3/5/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Schenzhen Smoore Technology Limited's FDA import refusal history?
Schenzhen Smoore Technology Limited (FEI: 3007471654) has 9 FDA import refusal record(s) in our database, spanning from 3/5/2009 to 4/29/2020.
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. Schenzhen Smoore Technology Limited's FEI number is 3007471654.
What types of violations has Schenzhen Smoore Technology Limited received?
Schenzhen Smoore Technology Limited 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 Schenzhen Smoore Technology Limited come from?
All FDA import refusal data for Schenzhen Smoore Technology Limited 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.