Shenzhen Boge Technology Co Ltd
⚠️ Moderate Risk
FEI: 3007254599 • Shenzhen • CHINA
FEI Number
3007254599
Location
Shenzhen
Country
CHINAAddress
E2 No. 6 Dong Entrepreneurial Ind Garden, , 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).
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2019 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/15/2019 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/14/2019 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/13/2019 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/13/2019 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/17/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/17/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/17/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/17/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/27/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/27/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/11/2008 | 66BAS44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 12/11/2008 | 66BAS44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shenzhen Boge Technology Co Ltd's FDA import refusal history?
Shenzhen Boge Technology Co Ltd (FEI: 3007254599) has 13 FDA import refusal record(s) in our database, spanning from 12/11/2008 to 3/15/2019.
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. Shenzhen Boge Technology Co Ltd's FEI number is 3007254599.
What types of violations has Shenzhen Boge Technology Co Ltd received?
Shenzhen Boge Technology 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 Shenzhen Boge Technology Co Ltd come from?
All FDA import refusal data for Shenzhen Boge 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.