Farsee Technology Co Ltd
⚠️ Moderate Risk
FEI: 3007374044 • Shenzhen • CHINA
FEI Number
3007374044
Location
Shenzhen
Country
CHINAAddress
Building No 8fifth Floor, , Shenzhen, , 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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/28/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/28/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/28/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/8/2009 | 66BAQ44NICOTINE DELIVERY SYSTEM | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Farsee Technology Co Ltd's FDA import refusal history?
Farsee Technology Co Ltd (FEI: 3007374044) has 5 FDA import refusal record(s) in our database, spanning from 4/8/2009 to 4/28/2009.
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. Farsee Technology Co Ltd's FEI number is 3007374044.
What types of violations has Farsee Technology Co Ltd received?
Farsee 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 Farsee Technology Co Ltd come from?
All FDA import refusal data for Farsee 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.