BAOJIE ELECTRONICS (SHENZHEN) LIMITED
⚠️ High Risk
FEI: 3016738529 • Shenzhen, Guangdong • CHINA
FEI Number
3016738529
Location
Shenzhen, Guangdong
Country
CHINAAddress
Gushu Community, No. 12 Xixiang Street Hangzhan Second Road; Baoan, Shenzhen, Guangdong, China
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 80FQMBANDAGE, ELASTIC | Division of Northern Border Imports (DNBI) | |
| 10/23/2024 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is BAOJIE ELECTRONICS (SHENZHEN) LIMITED's FDA import refusal history?
BAOJIE ELECTRONICS (SHENZHEN) LIMITED (FEI: 3016738529) has 9 FDA import refusal record(s) in our database, spanning from 10/23/2024 to 11/13/2024.
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. BAOJIE ELECTRONICS (SHENZHEN) LIMITED's FEI number is 3016738529.
What types of violations has BAOJIE ELECTRONICS (SHENZHEN) LIMITED received?
BAOJIE ELECTRONICS (SHENZHEN) LIMITED has been cited for 2 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 BAOJIE ELECTRONICS (SHENZHEN) LIMITED come from?
All FDA import refusal data for BAOJIE ELECTRONICS (SHENZHEN) 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.