Shenzhen Newland Electronic Ind. Co
⚠️ Moderate Risk
FEI: 3006744999 • Baoan Shenzhen China • CHINA
FEI Number
3006744999
Location
Baoan Shenzhen China
Country
CHINAAddress
Block 2 Zhao Fu Da Ind. Park, , Baoan Shenzhen China, , 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
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.
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).
Refusal History
Frequently Asked Questions
What is Shenzhen Newland Electronic Ind. Co's FDA import refusal history?
Shenzhen Newland Electronic Ind. Co (FEI: 3006744999) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2010 to 11/3/2010.
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 Newland Electronic Ind. Co's FEI number is 3006744999.
What types of violations has Shenzhen Newland Electronic Ind. Co received?
Shenzhen Newland Electronic Ind. Co 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 Shenzhen Newland Electronic Ind. Co come from?
All FDA import refusal data for Shenzhen Newland Electronic Ind. Co 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.