Shenzhen Shen Kelong Ltd
⚠️ Moderate Risk
FEI: 3007676948 • Shenzhen • CHINA
FEI Number
3007676948
Location
Shenzhen
Country
CHINAAddress
5/F, 41 bldg, Ruanwu Ind., Dachong,, Industry Zone Sahe Westroad, 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).
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.
Refusal History
Frequently Asked Questions
What is Shenzhen Shen Kelong Ltd's FDA import refusal history?
Shenzhen Shen Kelong Ltd (FEI: 3007676948) has 2 FDA import refusal record(s) in our database, spanning from 8/17/2009 to 2/24/2011.
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 Shen Kelong Ltd's FEI number is 3007676948.
What types of violations has Shenzhen Shen Kelong Ltd received?
Shenzhen Shen Kelong Ltd 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 Shen Kelong Ltd come from?
All FDA import refusal data for Shenzhen Shen Kelong 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.