Shenzhen Baolijie Technology Co., Ltd
⚠️ Moderate Risk
FEI: 3010297540 • SHENZHEN, GUANGDONG • CHINA
FEI Number
3010297540
Location
SHENZHEN, GUANGDONG
Country
CHINAAddress
Shajing Baoan Area, , 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
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/22/2023 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 12/19/2021 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 9/9/2021 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 3/25/2020 | 76JEQTOOTHBRUSH, POWERED | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 3/18/2020 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 11/22/2019 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 8/30/2017 | 76EFWTOOTHBRUSH, MANUAL | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 11/7/2016 | 76JEQTOOTHBRUSH, POWERED | Cincinnati District Office (CIN-DO) | |
| 8/9/2016 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 5/23/2016 | 76JEQTOOTHBRUSH, POWERED | Cincinnati District Office (CIN-DO) | |
| 5/13/2016 | 80LDQDEVICE, GENERAL MEDICAL | Cincinnati District Office (CIN-DO) | |
| 4/14/2016 | 76EFWTOOTHBRUSH, MANUAL | Cincinnati District Office (CIN-DO) | |
| 10/30/2015 | 76EFWTOOTHBRUSH, MANUAL | Cincinnati District Office (CIN-DO) | |
| 4/9/2015 | 76JEQTOOTHBRUSH, POWERED | Cincinnati District Office (CIN-DO) | |
| 2/24/2015 | 76JEQTOOTHBRUSH, POWERED | Division of Southeast Imports (DSEI) | |
| 1/31/2014 | 76JEQTOOTHBRUSH, POWERED | Seattle District Office (SEA-DO) | |
| 11/5/2013 | 76EFWTOOTHBRUSH, MANUAL | 333LACKS FIRM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Shenzhen Baolijie Technology Co., Ltd's FDA import refusal history?
Shenzhen Baolijie Technology Co., Ltd (FEI: 3010297540) has 18 FDA import refusal record(s) in our database, spanning from 11/5/2013 to 2/22/2023.
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 Baolijie Technology Co., Ltd's FEI number is 3010297540.
What types of violations has Shenzhen Baolijie Technology Co., Ltd received?
Shenzhen Baolijie Technology Co., Ltd has been cited for 5 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 Baolijie Technology Co., Ltd come from?
All FDA import refusal data for Shenzhen Baolijie 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.