Shenzhen Futian Light Industrial & Textile Prod Imp & Exp Co
⚠️ Moderate Risk
FEI: 3003606121 • Shenzhen, Guangdong • CHINA
FEI Number
3003606121
Location
Shenzhen, Guangdong
Country
CHINAAddress
Futian Trade & Business Bldg F/6, 51 Fuhua Road, 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
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
Frequently Asked Questions
What is Shenzhen Futian Light Industrial & Textile Prod Imp & Exp Co's FDA import refusal history?
Shenzhen Futian Light Industrial & Textile Prod Imp & Exp Co (FEI: 3003606121) has 1 FDA import refusal record(s) in our database, spanning from 6/28/2002 to 6/28/2002.
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 Futian Light Industrial & Textile Prod Imp & Exp Co's FEI number is 3003606121.
What types of violations has Shenzhen Futian Light Industrial & Textile Prod Imp & Exp Co received?
Shenzhen Futian Light Industrial & Textile Prod Imp & Exp 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 Futian Light Industrial & Textile Prod Imp & Exp Co come from?
All FDA import refusal data for Shenzhen Futian Light Industrial & Textile Prod Imp & Exp 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.